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Content INFORMAT˛VS IZDEVUMS ´RSTIEM UN FARMACEITIEM PAR Z´L˙M 2006-3 (21) 1 Saturs u Different types of marketing authorisations issued in the European Union. D. ˝ikute u SAM informs Use of the lamotrigine during early pregnancy an increased risk of cleft palate/cleft lip cannot be ruled out. Greater risk of stroke for older women taking tibolone (Livial). u Safety of Drugs Adverse reactions caused by BCG vaccine observed in Latvia during 2005 2006. Z. Lauska u Within the Database Adverse drug reactions associated with the use of bosentan (Tracleer ) for the treatment of primary pulmonary hypertension. D. Klincâre u Doctors Opinion Clostridium difficile infection caused by the use of antibiotics. U. Dumpis u Self education Antimicrobial Resistance. A. ÞileviLa u Clinical Trials TGN 1412: learning from adversity u Specially for Cito! Illegal Medicines. D. Schnädelbach u Changes within the Drug Register New products Re authorised products Changes within SPCs and PILs Withdrawn products Changes within the trade names Zâïu valsts aìentßra Bßtiska informâcija par zâïu reìistrâciju. D. ˝ikute 1 ZVA informç Lamotrigîna lietoðana grßtniecîbas laikâ un mutes dobuma ðíeltnes risks auglim 2 Insulta risks vecâka gadagâjuma sievietçm, kas lieto tibolonu (Livial) 3 Zâïu lietoðanas droðums BCG vakcînas izraisîtas komplikâcijas Latvijâ 2005. un 2006. gadâ. Z. Lauska 4 No ziòojumu datubâzes Veselîbas pasliktinâðanâs, sâkot bosentâna (Tracleer ) ordinçðanu primâras pulmonâlas hipertensijas gadîjumâ. D. Klincâre 5 ´rsta viedoklis Ar antibiotiku lietoðanu saistîtâ Clostridium difficile infekcija. U. Dumpis 6 Paðizglîtîba Miroorganismu rezistence pret antibakteriâliem preparâtiem. A. ÞileviLa 7 Zâïu klîniski pçtîjumi TGN 1412: jâmâcâs no kïßdâm 8 Speciâli Cito! Nelegâlâs zâles. D. —nçdelbahs 9 Izmaiòas Latvijas Republikas Zâïu reìistrâ Zâïu reìistrâ iekïautâs zâles 11 Pârreìistrçtâs zâles 12 Izmaiòas Zâïu aprakstos un Lietoðanas instrukcijâs 14 No Zâïu reìistra izslçgtâs zâles 16 Mainîts zâïu nosaukums 24 Ikviena praktizçjoða ârsta darbîba saistîta ar zâïu parakstîðanu un ieteikðanu pacientam. Zâles ir specifisks produkts, kura kvalitâti zâïu ikdienas lietotâjs (pacients) tik vienkârði nevar nedz vçrtçt, nedz paredzçt. Savukârt ârstam, parakstot zâles, jâbßt pilnîgi droðam un jâjßt atbildîba par to, ka viòa ordinçtais ârstniecîbas lîdzeklis ir kvalitatîvs, droðs un efektîvs vçlamâs terapeitiskâs darbîbas gßðanai. Minçto iemeslu dçï zâïu izplatîðana ir stingri reglamentçta nozare. Bßtisks pieturpunkts garajâ zâïu ceïâ no aktîvâs vielas atklâðanas lîdz pacientam ir zâïu reìistrâcija. Tâ ir starptautiskos un nacionâlos tiesîbu aktos reglamentçta procedßra. Reìistrâcija ir obligâta ikvienâm zâlçm, pirms tâs var sâkt parakstît un lietot. Reìistrâcijas nolßks konstatçt zâïu kvalitâtes, droðuma un efektivitâtes atbilstîbu noteiktâm prasîbâm. Kad minçtie raksturlielumi atzîti par labiem, tiek pieòemts lçmums zâles reìistrçt. Vispâratzîts, ka ârsta praksç jâlieto reìistrçtas zâles. Vçlamies Jums sniegt îsu informâciju par zâïu reìistrâciju. Kamçr Latvija vçl nebija iekïauta Eiropas Savienîbâ (ES), zâles valstî tika reìistrçtas tikai nacionâlâ zâïu reìistrâcijas procedßrâ. ES pastâv divas zâïu reìistrçðanas kategorijas centralizçtâ un nacionâlâ. Tâpçc lîdz ar Latvijas pievienoðanos ES, valstî ir spçkâ divi zâïu reìistrâcijas veidi: 1) ES centralizçtâ zâïu reìistrâcija; 2) nacionâlâ zâïu reìistrâcija. ES centralizçtâ zâïu reìistrâcija ES tiesîbu akti [Eiropas Parlamenta un padomes regula (EK) Nr. 726/2004 (2004. gada 31. marts)] nosaka, kuras zâles obligâti jâreìistrç centralizçti. Bßtiska informâcija par zâïu reìistrâciju Dace ˝ikute, Zâïu valsts aìentßras direktora vietniece

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Content

I N F O R M AT ÎV S I Z D E V U M S Â R S T I E M U N FA R M A C E I T I E M PA R Z Â L Ç M

2006-3 (21)

1

Saturs

u Different types of marketing authorisations issued in the European Union.D. Íikute

u SAM informs Use of the lamotrigine during early pregnancy �an increased risk of cleftpalate/cleft lip cannot be ruled out.Greater risk of stroke for older women taking tibolone (Livial).

u Safety of DrugsAdverse reactions caused by BCG vaccine observed in Latvia during 2005 �2006. Z. Lauska

u Within the DatabaseAdverse drug reactions associated with the use of bosentan (Tracleer®) forthe treatment of primary pulmonary hypertension. D. Klincâre

u Doctor�s OpinionClostridium difficile infection caused by the use of antibiotics. U. Dumpis

u Self � educationAntimicrobial Resistance. A. Þilevièa

u Clinical TrialsTGN 1412: learning from adversity

u Specially for Cito!Illegal Medicines. D. Schnädelbach

u Changes within the Drug RegisterNew productsRe � authorised productsChanges within SPCs and PILsWithdrawn productsChanges within the trade names

Zâïu valsts aìentûra

Bûtiska informâcija par zâïu reìistrâciju. D. Íikute 1ZVA informçLamotrigîna lietoðana grûtniecîbas laikâ un mutes dobuma

ðíeltnes risks auglim 2Insulta risks vecâka gadagâjuma sievietçm, kas lieto tibolonu (Livial) 3Zâïu lietoðanas droðumsBCG vakcînas izraisîtas komplikâcijas Latvijâ 2005. un 2006.

gadâ. Z. Lauska 4No ziòojumu datubâzesVeselîbas pasliktinâðanâs, sâkot bosentâna (Tracleer®) ordinçðanu

primâras pulmonâlas hipertensijas gadîjumâ. D. Klincâre 5Ârsta viedoklisAr antibiotiku lietoðanu saistîtâ Clostridium difficile

infekcija. U. Dumpis 6PaðizglîtîbaMiroorganismu rezistence pret antibakteriâliem

preparâtiem. A. Þilevièa 7Zâïu klîniski pçtîjumiTGN 1412: jâmâcâs no kïûdâm 8Speciâli Cito!Nelegâlâs zâles. D. Ðnçdelbahs 9Izmaiòas Latvijas Republikas Zâïu reìistrâZâïu reìistrâ iekïautâs zâles 11Pârreìistrçtâs zâles 12Izmaiòas Zâïu aprakstos un Lietoðanas instrukcijâs 14No Zâïu reìistra izslçgtâs zâles 16Mainîts zâïu nosaukums 24

Ikviena praktizçjoða ârsta darbîba saistîta ar zâïu parakstîðanuun ieteikðanu pacientam.

Zâles ir specifisks produkts, kura kvalitâti zâïu ikdienaslietotâjs (pacients) tik vienkârði nevar nedz vçrtçt, nedz paredzçt.Savukârt ârstam, parakstot zâles, jâbût pilnîgi droðam un jâjûtatbildîba par to, ka viòa ordinçtais ârstniecîbas lîdzeklis irkvalitatîvs, droðs un efektîvs vçlamâs terapeitiskâs darbîbasgûðanai. Minçto iemeslu dçï zâïu izplatîðana ir stingrireglamentçta nozare.

Bûtisks pieturpunkts garajâ zâïu ceïâ no aktîvâs vielasatklâðanas lîdz pacientam ir zâïu reìistrâcija. Tâ ir starptautiskosun nacionâlos tiesîbu aktos reglamentçta procedûra. Reìistrâcijair obligâta ikvienâm zâlçm, pirms tâs var sâkt parakstît un lietot.Reìistrâcijas nolûks � konstatçt zâïu kvalitâtes, droðuma unefektivitâtes atbilstîbu noteiktâm prasîbâm. Kad minçtieraksturlielumi atzîti par labiem, tiek pieòemts lçmums zâlesreìistrçt.

Vispâratzîts, ka ârsta praksç jâlieto reìistrçtas zâles.Vçlamies Jums sniegt îsu informâciju par zâïu reìistrâciju.

Kamçr Latvija vçl nebija iekïauta Eiropas Savienîbâ (ES), zâlesvalstî tika reìistrçtas tikai nacionâlâ zâïu reìistrâcijas procedûrâ.

ES pastâv divas zâïu reìistrçðanas kategorijas � centralizçtâun nacionâlâ. Tâpçc lîdz ar Latvijas pievienoðanos ES, valstî irspçkâ divi zâïu reìistrâcijas veidi:

1) ES centralizçtâ zâïu reìistrâcija;2) nacionâlâ zâïu reìistrâcija.

ES centralizçtâ zâïu reìistrâcija

ES tiesîbu akti [Eiropas Parlamenta un padomes regula (EK)Nr. 726/2004 (2004. gada 31. marts)] nosaka, kuras zâles obligâtijâreìistrç centralizçti.

Bûtiska informâcijapar zâïu reìistrâcijuDace Íikute,Zâïu valsts aìentûras direktora vietniece

Page 2: Saturs Bßtiska informâcija

Centralizçtâ zâïu reìistrâcija notiek Eiropas Zâïu aìentûrâ(Londonâ, Lielbritânijâ). Par centralizçti reìistrçtu zâïureìistrâcijas procedûru atbild Eiropas Zâïu aìentûra. Lçmumupar medikamenta reìistrçðanu pieòem Eiropas Komisija (EK). Jamedikaments reìistrçts centralizçti, EK lçmums ir saistoðs visâmES dalîbvalstîm. Tas nozîmç, ka zâles drîkst izplatît visâs ES valstîs.Pirms zâïu izplatîðanas kâdâ dalîbvalstî, reìistrâcijas îpaðniekam(raþotâjsabiedrîbai) par to jâpaziòo nacionâlai zâïu aìentûrai. Nevisas centralizçti reìistrçtas zâles nekavçjoties ir pieejamasLatvijas tirgû. Jâpatur prâtâ, ka ârstam tomçr ir tiesîbas un iespçjasparakstît jebkuru centralizçti reìistrçtu medikamentu. Minçtâgadîjumâ tas var tikt individuâli piegâdâts pacientam Latvijaslikumos paredzçtâ kârtîbâ. Informâciju par piegâdes iespçju unzâïu cenu var saòemt aptiekâs.

Nacionâlâ zâïu reìistrâcija

Nacionâlâs reìistrâcijas gadîjumâ par zâïu reìistrçðanu atbildkatras ES valsts nacionâlâ zâïu aìentûra. Pastâv vairâkinacionâlâs zâïu reìistrâcijas procedûru veidi, to vidû:l Savstarpçjâs atzîðanas procedûra. Zâles var reìistrçt

ðai procedûrâ, ja tâs jau reìistrçtas kâdâ ES valstî. Pirmâ valsts,kurâ zâles reìistrçtas, kïûst par atsauces valsti. Pârçjâs valstis,kas iesaistâs ðai procedûrâ, sauc par iesaistîtâm valstîm. Atsaucesvalsts (sadarbîbâ ar iesaistîtâm valstîm) vada (saskaòo)reìistrâcijas procedûru, zâïu lietoðanas droðuma problçmurisinâðanu, kâ arî lçmumu pieòemðanu un ievieðanu.

ES savstarpçjâs atzîðanas procedûrâ reìistrçtâm zâlçm Zâïuapraksti visâs iesaistîtâs valstîs ietver vienâdu informâciju.l Decentralizçtâ procedûra. Reìistrâcijas îpaðnieks

iesniedz pieteikumu zâïu reìistrçðanai decentralizçtâ procedûrâvairâkâs ES valstîs vienlaikus. Ðai procedûrâ zâles var reìistrçt,ja, iesniedzot reìistrâcijas pieteikumu (iesniegumu), zâles vçl navbijuðas reìistrçtas nevienâ ES valstî.

Zâïu apraksti visâs iesaistîtâs valstîs ietver vienâduinformâciju.l Neatkarîgâ nacionâlâ procedûra. Raþotâjsabiedrîba

nolemj reìistrçt zâles atseviðíâs valstîs, piemçram, Latvijâ vaivçl kâdâs citâs ES valstîs.

Minçtie trîs nacionâlâs zâïu reìistrâcijas veidi atðíiras tikaiar procedûras izpildîjumu. Savstarpçjâs atzîðanas undecentralizçtai zâïu reìistrâcijas procedûrai kopîgs ir tas, kavairâkâs (iesaistîtâs) ES dalîbvalstîs zâïu reìistrâcijas, kâ arîpçcreìistrâcijas uzraudzîbas procedûras notiek saskaòoti.

Jebkura zâïu reìistrâcijas procedûra nodroðina, ka ârstaun sabiedrîbas rîcîbâ nonâk ne tikai stingri pârbaudîtaszâles, bet arî pastâvîgi atjauninâta uz zinâtniskas izpçtesdatiem balstîta informâcija par tâm: Zâïu apraksts unLietoðanas instrukcija.

Taèu, ja pacienta ârstçðanai nepiecieðamâs zâles navreìistrçtas Latvijâ un tâs nevar aizstât neviens cits LatvijasRepublikas Zâïu reìistrâ iekïauts zâïlîdzeklis, ârsts var parakstîtarî Latvijâ nereìistrçtas zâles, to pamatojot. Ja vien iespçjams,ieteicams parakstît zâles, kuras ir apstiprinâtas lietoðanai EiropasSavienîbâ un kuru raþoðana atbilst labas raþoðanas praksesnosacîjumiem.

ZVA ik gadu izdod Latvijas Republikas Zâïu reìistru. Tajâpublicçts gan Latvijâ nacionâli, gan ES centralizçti reìistrçtu,gan arî paralçli importçtu zâïu saraksts.

Izdevumâ zâïu iedalîjumam izmantota ATÍ (anatomiskiterapeitiski íîmiska) klasifikâcija, kas balstâs uz zâïu iedalîðanugrupâs un apakðgrupâs pçc to iedarbîbas uz orgâniem un orgânusistçmâm, kâ arî uz to terapeitiskâm, farmakoloìiskâm un íîmiskâmîpaðîbâm. Klasifikâcijâ tiek lietoti zâïu starptautiskie nepatentçtienosaukumi (aktîvo vielu nosaukumi). Zâïu ATÍ kodu veido burtuun ciparu kombinâcijas. Tâs vienai un tai paðai aktîvai vielaiatkarâ no zâïu lietoðanas indikâcijâm, devas un zâïu formas varbût vairâkas. Tas nozîmç, ka vienai aktîvai vielai var bût vairâkiATÍ kodi. Piemçram, prednizolonu var lietot âdas, acu slimîbuun sistçmisku hormonâlu traucçjumu ârstçðanâ.

Bûtiski, ka minçtais izdevums sniedz priekðstatu par Latvijâlietoðanai apstiprinâtu zâïu loku, kas sistematizçts atbilstoðizâïlîdzekïa darbîbai. Iesakâm Jums ðo izdevumu par palîgu ikdienasdarbâ: piemçram, alternatîvas terapijas izvçlç vai arî lainoskaidrotu Latvijâ pieejamas analoìiskâs zâles.

Ârstam bûtiski zinât, ka, papildinot ar jaunu informâcijuES centralizçti un Latvijâ nacionâli reìistrçtu zâïu reìistrosiekïautos Zâïu aprakstus un Lietoðanas instrukcijas, reìistrosnotiek pastâvîgas pârmaiòas.

Tâpçc, lai vienmçr gûtu aktuâlus (jaunâkos) datus parzâlçm, ko sniedz Latvijâ spçkâ esoði Zâïu apraksti, iesakâmðâdas interneta mâjaslapas:

� ar Latvijâ nacionâli reìistrçtu Zâïu aprakstiem Jûs varatiepazîties ZVA mâjaslapâ, lietojot saiti www.zva.gov.lv → LRZâïu reìistrs → Medikamentu meklçðana → Meklçt pçc:(jâieraksta zâïu oriìinâlnosaukums vai starptautiskaisnosaukums) → aktivizçt lauku �Meklçt�;

� ar ES centralizçti reìistrçtu Zâïu aprakstiem un cituzinâtnisku informâciju par medikamentu (arî latvieðu valodâ)varat iepazîties Eiropas Zâïu aìentûras (EMEA) mâjaslapâ,lietojot saiti www.emea.eu.int → Human Medicines → List ofauthorised Products (EPARs) → List of products (zâïuoriìinâlnosaukumi alfabçta kârtîbâ).

Cienîjamie kolçìi, ja Jums nepiecieðama papildinformâcija parrakstâ izklâstîtiem jautâjumiem, aicinâm vçrsties Zâïu valstsaìentûrâ pa tâlruni 7078424 vai rakstît elektroniskâ pasta adresç[email protected].

2 Cito! � 3 (21) Zâïu valsts aìentûra

Cienîjamie kolçìi,

aicinâm ziòot Zâïu valsts aìentûrai par visiem novçrotiem bûtiskiemveselîbas traucçjumiem (blaknçm), ko iespçjams saistît ar zâïu lietoðanu!

Ziòojuma veidlapu varat izdrukât no ZVA mâjaslapashttp://www.zva.gov.lv/pakalpojumi/zmonitor.html.

Ziòojuma veidlapa tiek pievienota arî katram �Cito!� eksemplâram.

Page 3: Saturs Bßtiska informâcija

Zâïu valsts aìentûra Cito! � 3 (21) 3

ZVA informç

Nesen veikta Ziemeïamerikas grûtniecîbas un pretepilepsijas lîdzekïulietoðanas reìistra [North American Antiepileptic Drug (NAAED)Pregnancy Registry] datu analîze. Tâ sniedz informâciju par palielinâtumutes dobuma ðíeltnes risku auglim, ko saista ar lamotrigîna lietoðanuagrînâ grûtniecîbas periodâ (pirmos trîs grûtniecîbas mçneðos).

Lamotrigîns pieder pie pretepilepsijas lîdzekïiem. Tas indicçtsepilepsijas un bipolâru afektîvu traucçjumu ârstçðanâ.

Minçtâ reìistra datu analîze aptver 564 gadîjumus, kuros sievietesgrûtniecîbas pirmâ trimestrî saòçmuðas lamotrigîna monoterapiju. Piecosgadîjumos piedzimuði bçrni ar mutes dobuma ðíeltni: trîs ar izolçtu,nesindromisku aukslçju ðíeltni un divi ar izolçtu, nesindromisku lûpuðíeltni (bez aukslçju ðíeltnes).

Tâdçjâdi reìistra ietvaros konstatçtais mutes dobuma ðíeltnesbieþums ir 8,9 /1000.

Savukârt minçtâs patoloìijas bieþums iedzîvotâju vidû (vispârçjâpopulâcijâ) ir 0,37/1000 [saskaòâ ar Brighemas un sievieðu slimnîcasuzraudzîbas programmas (Brigham and Women�s Hospital (BWH)Surveillance Program) datiem ].

Konstatçts, ka Ziemeïamerikas grûtniecîbas un pretepilepsijas lîdzekïulietoðanas reìistra ietvaros veiktâ analîze neliecina par paaugstinâtu kopçjovispârçju bûtisku iedzimtu patoloìiju bieþumu.

Ðobrîd citos pçtîjumos gûtie dati neapstiprina Ziemeïamerikasgrûtniecîbas un pretepilepsijas lîdzekïu lietoðanas reìistra izpçtes atrades.

Lamotrigîna lietoðana grûtniecîbas laikâ un mutesdobuma ðíeltnes risks auglim

Tomçr Lamictal (lamotrigîns) raþotâjsabiedrîba sadarbîbâ ar EiropasSavienîbas atbildîgâm zâïu pârraudzîbas iestâdçm nolçmusi jaunoinformâciju ieviest zâïu dokumentâcijâ.

2006. gada 19. jûnijâ Lamictal (lamotrigîns) raþotâjsabiedrîbaGlaxoSmithKline Latvia SIA Latvijas speciâlistiem izplatîja �Vçstuliârstam�, kurâ sadarbîbâ ar ZVA informçja par jauno atradi. Ar �Vçstuliârstam� varat iepazîties ZVA mâjaslapas www.zva.gov.lv sadaïâ�Jaunumi�.

Jâpatur prâtâ:l sievietes, kas saòem lamotrigînu, jâbrîdina informçt ârstu, ja

grûtniecîba tiek plânota vai tâ iestâjusies lamotrigîna lietoðanas laikâ;l ikvienâ gadîjumâ, parakstot lamotrigînu grûtniecei, jâvçrtç

iespçjamais mutes dobuma ðíeltnes risks auglim, ko var saistît arlamotrigîna lietoðanu agrînâ grûtniecîbas periodâ, un paredzamaisieguvums, ko zâïu lietoðana var sniegt grûtniecei;l jâiegaumç, ka jâvairâs no pçkðòas pretepilepsijas lîdzekïu

lietoðanas pârtraukðanas, jo tâ var izraisît lçkmju atjaunoðanos, radotsmagas sekas gan mâtei, gan auglim;l minçtâ informâcija attiecas uz visiem lamotrigîna preparâtiem,

kas reìistrçti Latvijâ;l jâiegaumç, ka arî citu pretepilepsijas lîdzekïu lietoðana

grûtniecîbas laikâ var radît iedzimtu defektu risku.

Ðâ gada 19. jûnijâ Livial (tibolons) raþotâjsabiedrîba Organon Latvijasspeciâlistiem izplatîja �Vçstuli ârstam�, kurâ sadarbîbâ ar ZVA informçjapar LIFT (Long � term Intervention on Fractures with Tibolone) pçtîjumaanalîzes pagaidu rezultâtiem. Tie liecina par paaugstinâtu insulta riskuvecâka gadagâjuma sievietçm, kas lieto tibolonu.

Tibolons ir estrçna atvasinâjums, kas organismâ âtri pârvçrðas partrim metabolîtiem. Diviem no tiem piemît estrogçna aktivitâte, betvienam � gestagçna un androgçna.

Latvijâ reìistrçtas Livial tabletes, kas satur 2,5 mg tibolona.Ðobrîd Latvijâ Livial (tibolons) apstiprinâts lietoðanai ðâdâs

indikâcijâs:l estrogçnu deficîta simptomu ârstçðanai sievietçm

pçcmenopauzes vecumâ. Zâles drîkst sâkt lietot gadu pçc menopauzesiestâðanâs;

l osteoporozes attîstîbas kavçðanai pçcmenopauzes vecumasievietçm, kurâm ir palielinâts kaulu lûzuma risks gadîjumâ, ja sievietenepanes vai viòai ir kontrindicçtas cita veida zâles, kas apstiprinâtasosteoporozes profilaksei.

LIFT pçtîjums sâkâs 2001. gadâ. Tas bija placebo kontrolçtsnejauðinâts pçtîjums, kurâ tika iesaistîtas 4538 sievietes. Viòu vidçjaisvecums bija 68 gadi (60 � 85 gadi). Vidçjais pacienðu novçroðanas ilgums� 2,75 gadi. Pçtîjuma mçríis � noskaidrot 1,25 mg lielas tibolona devasiedarbîgumu osteoporozes ârstçðanâ. Minçtai indikâcijai ðâda tibolonadeva nebija apstiprinâta.

2005. gada augustâ Pçtîjuma uzraudzîbas komiteja ziòoja, ka tibolonalietotâju grupâ (salîdzinot ar placebo grupu) novçrots lielâks insultagadîjumu skaits. 2006. gada janvârî Pçtîjuma uzraudzîbas komiteja ieteicapçtîjumu beigt âtrâk nekâ paredzçts, jo izpçtes datu analîze liecinâja, ka

minçtâ atrade nav mainîjusies. Tika atzîts, ka pçtîjumâ iesaistîtâm pacientçmzâïu lietoðanas ieguvuma/riska attiecîba ir negatîva. Novçrotais insultabieþums placebo lietotâju grupâ bija 1,8 uz 1000 sievieðu gadiem. Savukârttibolona lietotâju grupâ tas bija 4,1 uz 1000 sievieðu gadiem. Tiek lçsts, kaatbilstoði izpçtes datiem piecu gadu laikâ uz 1000 sievietçm, kas lietotibolonu (salîdzinot ar zâïu nelietotâjâm) papildus sagaidâmi 11, 5 insultagadîjumi.

Lai gan minçtie dati balstâs uz LIFT pçtîjuma analîzes pagaidu atradiun galarezultâti gaidâmi ðâ gada nogalç, Livial Zâïu aprakstâ ieviestigrozîjumi:

l norâdîts, ka Livial kontrindicçts, ja pacientei anamnçzç irjebkâda veida arteriâla trombemboliska slimîba (piemçram, insults, pârejoðigalvas smadzeòu asinsrites traucçjumi, miokarda infarkts, stenokardija);

l zâïu parakstîtâji tiek brîdinâti par klîniskâs izpçtes datiem, kasliecina par paaugstinâtu insulta risku vecâka gadagâjuma sievietçm(vidçjais vecums 68 gadi) mazas tibolona devas (1,25 mg) lietoðanasgadîjumâ.

Latvijâ nav reìistrçtu indikâciju Livial lietoðanai devâ 1,25 mg.Paaugstinâts insulta risks, par ko liecina LIFT pçtîjums, novçrots

vecâkâm sievietçm, nekâ pacientes, kurâm tibolonu ordinç menopauzessimptomu mazinâðanai.

Jâpatur prâtâ, ka saskaòâ ar Livial Zâïu aprakstu iespçjami mazâkareìistrçtâ zâïu deva jâordinç iespçjami îsâku laiku. Visos gadîjumos vismazvienreiz gadâ ârstam kopâ ar pacienti rûpîgi jâvçrtç ieguvums, ko sniedzzâïu lietoðana, un iespçjamais blakòu risks.

Ar �Vçstuli ârstam� par Livial un LIFT pçtîjumâ identificçto insultarisku varat iepazîties ZVA mâjaslapas www.zva.gov.lv sadaïâ �Jaunumi�.

Insulta risks vecâka gadagâjuma sievietçm,kas lieto tibolonu (Livial)

Page 4: Saturs Bßtiska informâcija

Latvijâ saslimstîba ar tuberkulozi (TB) visâs iedzîvotâjuvecumgrupâs (arî bçrniem lîdz 15 gadu vecumam) sâka palielinâties 20.gadsimta 90. gadu sâkumâ.

1992. gadâ bçrnu saslimstîba ar TB bija tikai 6,1/100 000. Katru gaduturpinot pieaugt, 2004. gadâ tâ sasniedza jau 30,2/100 000.

Tuberkulozes infekcijas avots parasti ir plauðu TB slimnieks, kasslimîbas ierosinâtâju Mycobacterium tuberculosis izdala apkârtçjâ vidçrunâjot, klepojot, ðíaudot utt. Ar epidemioloìiski bîstamâm TB formâmLatvijâ parasti slimo pieauguðie, taèu atseviðíos gadîjumos tâsiespçjamas arî pusaudþiem un bçrniem.

Infekcijas progresçðanu ietekmç� bçrna vecums;� imûnsistçmas aktivitâte;� mikobaktçriju daudzums, kas nonâk organismâ;� mikobaktçriju virulence;� saskares ilgums, regularitâte u. c.

Tâpat kâ daudzâs valstîs, kur saslimstîba ar TB vçl joprojâm iraugsta, Latvijâ jaundzimuðo vakcinâcija ar BCG vakcînu iekïautaImunizâcijas valsts programmâ. Tas nozîmç, ka visiem bçrniemiespçjami drîz pçc dzimðanas jâsaòem prettuberkulozes vakcîna (janav kontrindikâciju).

Ja TB ierosinâtâjs nokïûst zîdaiòa organismâ un notiek inficçðanâs,slimîba var manifestçties pat lîdz 43% gadîjumu, savukârt bçrniem 1 �5 gadu vecumâ � lîdz 24% gadîjumu, pusaudþiem � lîdz 15%, betpieauguðiem cilvçkiem tikai 5 � 10% gadîjumu visa mûþa laikâ.

Visaugstâkais saslimðanas risks ir zîdaiòiem. Turklât viòiem pierâdîtainfekcijas ìeneralizâcija, kas klîniski izpauþas meningîta vai miliâras TBveidâ. Arî Latvijâ pçdçjos gados zîdaiòi veido bûtisku daïu no tiembçrniem, kas saslimuði ar TB: 2004. gadâ � 16 zîdaiòu, bet 2005. gadâ �10 zîdaiòu (atbilst 15% ar TB saslimuðu bçrnu aizvadîtâ gadâ).

Kâ zinâms, BCG vakcîna nepasargâ no saslimðanas ar plauðu TB.Tomçr pierâdîts, ka inficçðanâs gadîjumâ tâ ierobeþo mikobaktçrijuvairoðanos un hematogçnisku izplatîðanos, pasargâjot zîdaiòus unagrîna vecuma bçrnus. Minçtais fakts balsta vakcinâcijas lietoðanutûlît pçc dzimðanas. Ðî prakse attaisnojas arî Latvijâ � pastâvot augstaisaslimstîbai ar TB, smagas TB formas agrîna vecuma bçrniem Latvijâvçrojamas reti.

Kopð 2005. gada Latvijâ veselu jaundzimuðo vakcinçðanu veictikai ar BCG Vaccine SSI, Statens Serum Institut, Dânijas celms 1331.Tâ ir vienîgâ valstî reìistrçtâ prettuberkulozes vakcîna, kas indicçtaaktîvai imunizâcijai pret TB. Vakcîna satur dzîvu, novâjinâtuMycobacterium bovis. Pirms tam kopð 90. gadu sâkuma Latvijâ tikalietota BCG vaccine, Aventis Pasteur SA, Francija, celms 1077.

Aprakstîtas ðâdas komplikâcijas, kas var rasties pçc BCG vakcînassaòemðanas (1 � 10%):

� ilgstoðs infiltrâts vai èûla injekcijas vietâ;� reìionâla limfadenopâtija;� lupoidâla reakcija (parasti injekcijas vietâ);� osteomielîts;� diseminçta infekcija.

Vakcînas komplikâciju risku var ietekmçt vakcînas �stiprums�(mikobaktçriju skaits vienâ devâ var bût robeþâs 50 tk � 3 mlj), neprecîzavakcînas ievadîðanas tehnika (zemâdâ ievadîta vakcîna veicina abscesarisku), pârsniegta vakcînas deva, kâ arî pârmaiòas bçrna imunogrammâ.

No 2005. gada jûlija lîdz 2006. gada 15. martam Tuberkulozes unplauðu slimîbu valsts aìentûras (TPSVA) bçrnu nodaïâ tika konsultçti23 BCG vakcînas izraisîti komplikâciju gadîjumi, par ko informçtaSabiedrîbas veselîbas aìentûra, nosûtot steidzamâ paziòojumaveidlapu Nr. 058/u.

Minçtos gadîjumos vakcînu bija saòçmuði 9 zçni un 14 meitenes.Bçrnu dzimðanas masa bija 1950 � 5060 g (vidçjâ masa 3650 g).

BCG vakcîna ievadîta:� 12 gadîjumos Rîgas dzemdîbu namâ;� trîs gadîjumos P. Stradiòa klîniskâs universitâtes slimnîcas

dzemdîbu nodaïâ;� divos gadîjumos Bulduru slimnîcas dzemdîbu nodaïâ;� pa vienam gadîjumam Limbaþu, Aizkraukles, Jelgavas,

Valmieras, Talsu slimnîcas dzemdîbu nodaïâ un Rîgas Ziepniekkalnaveselîbas centrâ.

Vakcinâcija veikta 2. � 3. mûþa dienâ, izmantojot vakcînas sçrijas104008 D, 104027 C.

Reìistrçtâs komplikâcijas:� reìionâls limfadenîts kreisâs paduses apvidû � 17 gadîjumu,

konstatçti laikâ no trim nedçïâm lîdz astoòiem mçneðiem (vidçji piecumçneðu vecumâ);

� infiltrâts vakcinçðanas vietâ � èetri gadîjumi, pârmaiòaskonstatçtas 3,3 mçneðu vecumâ;

� palielinâti kreisâs puses supraklavikulârie limfmezgli � divigadîjumi. Vienâ no tiem limfmezglu palielinâðanâs novçrota piecumçneðu vecumâ (bçrns vakcinçts viena mçneða un vienas nedçïasvecumâ). Otrâ gadîjumâ limfmezglu palielinâðanâs novçrota vienamçneða vecumâ (bçrns vakcinçts treðajâ mûþa dienâ).

12 no 23 gadîjumiem tika ordinçta imunologa konsultâcija.Konsultâcijâ tika gûti ðâdi dati:

� 10 gadîjumos imûndeficîta sindroma pazîmes nekonstatçja;� vienâ gadîjumâ konstatçja vâjinâtu fagocitâru funkciju;� vienâ gadîjumâ vecâki bija atteikuðies izdarît imunogrammu.Komplikâciju íirurìisku ârstçðanu lietoja vienpadsmit

gadîjumos:� desmit limfmezglu ekstirpâcija;� vienâ supraklavikulârâ limfmezgla punkcija.Vienâ gadîjumâ, kurâ tika plânota limfmezgla ekstirpâcija, vecâki

atteicâs no íirurìiskas iejaukðanâs.No operâcijas materiâla izdarîts uzsçjums TPSVA bakterioloìiskajâ

laboratorijâ, un identificçta vakcînâ izmantotâ M. bovis.Divos gadîjumos pçc limfmezgla ekstirpâcijas konstatçts recidîvs.

Limfmezgla palielinâðanâs un fistula: specifisks process, kasapstiprinâts histoloìiski. Vienâ no gadîjumiem 2006. gada 3. martâbçrnam sâkta specifiska terapija ar diviem prettuberkulozesmedikamentiem (izoniazîdu un rifampicînu), kas plânota vismazpusgadu. Otrâ gadîjumâ pçc limfmezgla atkârtotas ekstirpâcijas

Zâïu lietoðanas droðums

4 Cito! � 3 (21) Zâïu valsts aìentûra

BCG vakcînas izraisîtas komplikâcijasLatvijâ 2005. un 2006. gadâZita Lauska,Dr., Tuberkulozes un plauðu slimîbu valsts aìentûra

Page 5: Saturs Bßtiska informâcija

specifiska terapija pagaidâm nav ordinçta, jo bçrna imunogrammânovirzes no normas nav konstatçtas.

Labâkais veids kâ pasargât bçrnus no saslimðanas ar TB:

� agrîni atklât visus jaunos epidemioloìiski bîstamos TBgadîjumus un nodroðinât to veiksmîgu izârstçðanu;

� apzinât un laikus izmeklçt visas iespçjamâs kontaktpersonas,lai atklâtu jaunus TB gadîjumus;

� izglîtot sabiedrîbu, sniedzot informâciju par TB inficçðanâsceïiem, slimîbas simptomiem, ârstçðanâs iespçjâm, u.c.;

� pastâvot augstai kopçjai saslimstîbai ar TB valstî, saglabâtiepriekðçjo BCG vakcinâcijas programmu.

Ieteikumi

1. Ievçrojot paðreizçjo kopçjo saslimstîbu ar TB Latvijâ un cituvalstu pieredzi, kura apliecina klîniski smago TB formu un bçrnumirstîbas pieaugumu pçc vakcinâcijas pârtraukðanas, navvçlams pârtraukt veselu jaundzimuðo vakcinâciju.

2. Stingri ievçrot kontrindikâcijas vakcinçjamo personu atlasç,kâ arî vakcînas glabâðanas, transportçðanas un veikðanasprasîbas.

3. Uzlabojoties epidemioloìiskajai situâcijai valstî, pârskatîtpaðreizçjo potçðanas kalendâru, saglabâjot BCG vakcinâcijuaugsta TB saslimðanas riska grupas bçrniem.

Primâra pulmonâla hipertensija ir reta patoloìija. Literatûras datiliecina, ka to novçro 1 � 2 cilvçkiem no miljona iedzîvotâju [1].

2005. gada septembrî Latvijas Kardioloìijas centrâ pçc palîdzîbasvçrsâs 28 gadus veca daugavpiliete. Viòa sûdzçjâs par progresçjoðuelpas trûkumu, kas sâcies pirms diviem gadiem. Slimniecei anamnçzçbijusi arî atkârtota plauðu asiòoðana. Ehokardiogrâfiska (EhoKG)izmeklçðana liecinâja par stipru labâs sirds puses dilatâciju un plauðuhipertensiju, sekundâru mitrâlu, trikuspidâlu un pulmonâluregurgitâciju. Arî plauðu datortomogrâfiskâ (DT) izmeklçðanâ tikakonstatçta stipri palielinâta labâ sirds puse. DT angiogrâfijanesniedza datus par plauðu artçrijas trombemboliju. Laboratoriskâsanalîzçs bija nedaudz paaugstinâts kreatinîna lîmenis, bet citunozîmîgu novirþu nebija. Elektrokardiogrâfiski (EKG) konstatçjasinusa tahikardiju, labâ priekðkambara un kambara hipertrofiju.Slimniecei sâka ordinçt amlodipînu (Norvasc®), tâ devu pakâpeniskipalielinot lîdz 10 mg dienâ (lielâka medikamenta deva izraisîjahipotensiju). Vienlaikus viòa saòçma tik lielu varfarîna devu, lai INRbûtu 2 � 3.

2005. gada oktobrî slimniecei veica sirds zondçðanu un tieðuasinsspiediena mçrîðanu. Spiediens kreisajâ kambarî un aortâ par 6 mmHg pârsniedza spiedienu labajâ kambarî un plauðu artçrijâ. Tasapstiprinâja pulmonâlas hipertensijas diagnozi. Potîðu tûskas dçïamlodipînu nomainîja pret lerkanidipînu (Lercapin®) pa 20 mg dienâ.

Tahikardijas mazinâðanai 2005. gada decembrî terapijai pievienojanebivololu (Nebilet®) pa 2,5 mg dienâ. Minçtâ terapija elpas trûkumuslodzes laikâ nedaudz mazinâja. Slimniece jutâs samçrâ apmierinoði.

2006. gada janvârî terapijai tika pievienots bosentâns (Tracleer®)pa 62,5 mg divas reizes dienâ (ieteiktâ devâ).

Bosentâns ir endotelîna-1 receptoru antagonists, kas indicçtspulmonâlas hipertensijas ârstçðanai. ASV, Kanâdâ un Eiropâ minçtaismedikaments tiek ieteikts slimniekiem ar primâru pulmonâlu hipertensiju,III un IV klasi pçc NYHA (New York Heart Association) klasifikâcijas.

Klînisko pçtîjumu dati liecina, ka bosentâns uzlabo slodzes toleranci,ehokardiogrâfiskos un doplerogrâfiskos raksturlielumus, mazina sirdsmazspçju (ietekmç funkcionâlâs klases raksturlielumus) un paildzina

Zâïu valsts aìentûra Cito! � 3 (21) 5

No ziòojumu datubâzes

Veselîbas pasliktinâðanâs, sâkot bosentâna (Tracleer®)ordinçðanu primâras pulmonâlas hipertensijas gadîjumâDace Klincâre,Dr. med., Paula Stradiòa klîniskâ universitâtes slimnîca

laiku lîdz jaunam uzliesmojumam [2]. Ðobrîd nav datu, ka lîdz ðimmedikaments bûtu lietots arî Latvijâ.

2006. gada 1. februârî slimniece vçrsâs Latvijas Kardioloìijas centrâar sûdzîbâm par sâpçm krûðkurvî, kuras saistîtas ar elpoðanu (�sâpotplauðas�). Viòa sûdzçjâs arî par ïoti strauju elpas trûkuma pieaugumu.Pacienti izmeklçjot, netika novçrotas bûtiskas EKG un bioíîmiskoraksturlielumu pârmaiòas. Bosentâna deva tika mazinâta uz pusi (31,25mg divas reizes dienâ). Tomçr sâpes krûðkurvî un elpas trûkumsprogresçja. 2006. gada 3. februârî medikamenta ordinçðana tikapârtraukta.

6. februârî slimnieci ievietoja Latvijas Kardioloìijas centrâ. PçcEhoKG datiem, salîdzinot ar 2005. gada oktobri, nedaudz bija pieaudzisspiediens labajâ sirds kambarî (no 85 uz 100 mm Hg), citu bûtiskupârmaiòu nebija. Ievçrojot slimîbas nopietnîbu, relatîvu slimniecesveselîbas stabilitâti, saòemot tikai lerkanidipînu, nebivololu un varfarînu,kâ arî ïoti strauju stâvokïa pasliktinâðanos, sâkot bosentâna lietoðanu,tika nolemts bosentâna ordinçðanu neatsâkt. Slimniece turpinâja saòemtiepriekðçjo terapiju.

Slimnieces veselîbas pasliktinâðanâs un bosentâna lietoðanascçloniskâ sakara ticamîbu balsta ðâdi fakti:

1) nebija iespçjams konstatçt citus (alternatîvus) veselîbas stâvokïapasliktinâðanâs iemeslus;

2) pârtraucot bosentâna lietoðanu, slimnieces veselîba uzlabojâs.Slimniece papildus saòçma arî citus medikamentus. Tâpçc ðai

gadîjumâ nav iespçjams noteikt, vai stâvokïa pasliktinâðanos izraisîjatikai bosentâns viens pats vai arî tâ mijiedarbîba ar citiem medikamentiem(lerkanidipînu, nebivololu un varfarînu).

Vçres1. Braunwald E., Zipes DP., Libby P. (eds) Heart Disease, ed. 6th, WB

Saunders Company, Philadelphia, 2084 - 2097.2. Galie N., Torbicki A., Barst R., Dartevelle P., Haworth S., Higen-

bottam T., Olschewski H., Peacock A., Pietra G., Rubin LJ., SimonneauG. (2004) Guidelines on diagnosis and treatment of pulmonaryarterial hypertension. Eur. Heart J., 2004; 25; 2243 - 2278.

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6 Cito! � 3 (21) Zâïu valsts aìentûra

Ârsta viedoklis

Bieþa antibiotiku lietoðanas blakne ir Clostridium difficilesuperinfekcija, kas veido 10 � 25% antibiotiku lietoðanas izraisîtascaurejas gadîjumu. Tâs ìençze saistîta ar normâlâs zarnu mikrofloraslîdzsvara pârmaiòâm antibakteriâlâs terapijas gaitâ, kas rada iespçjuðim patogçniskajam mikroorganismam savairoties. Caurejas bieþumsatkarîgs no izvçlçtâs antibiotikas, kâ arî slimnieka vispârçjâ stâvokïa.Visbieþâkie riska faktori, kas saistâmi ar paaugstinâtu caurejas risku,ir slimnieka vecums (> 65 gadi), imûnsupresija, atraðanâs intensîvâsterapijas nodaïâ un ilgstoða hospitalizâcija. Praktiski jebkuraantibiotika var izraisît caureju, tomçr bieþâk to novçro, ja lietoklindamicînu (linkomicînu), aminopenicilînu kopâ ar klavulanâtu vaicefalosporînus. Antibiotiku kombinâcijas lietoðana palielina caurejasrisku. Sakarâ ar seviðíi patogçniska un multirezistenta(ciprofloksacîns, metronidazols) celma izplatîbu pasaulç Clostridiumdifficile infekcija pçdçjos gados ir kïuvusi îpaði aktuâla.

Klîniskâ aina

Klîniski Clostridium difficile infekcija var izpausties no nedaudzðíidras vçdera izejas lîdz smagam septiskam stâvoklim ar drudzi unstipru iekaisumu. Îpaði nopietnos gadîjumos tâ var izraisîtpseidomembranozo kolîtu, zarnu toksisku paplaðinâðanos(megakolonu) un perforâciju. Jaunâ multirezistentâ celma, par kuraklâtieni Latvijâ nav datu, klîniskâ aina ir daudz smagâka.

Diagnostika

Clostridium difficile infekciju vislabâk diagnosticçt, nosakotizkârnîjumos A un B toksînu ar enzîmu imunoloìiskâ testa palîdzîbu.Testam ir augsta specifitâte, bet 10 � 20% gadîjumu tas var bûtnegatîvs. Atbilde pieejama nâkamajâ dienâ. Kaut arî uzsçjumsuzskatâms par zelta standartu, tas prasa laiku, ir tehniski sareþìîtsun dârgs. Polimerâzes íçdes metodes lietoðanai toksînu diagnostikâir ïoti laba iespçja, tomçr tâs indikâcijas joprojâm nav pilnîbâizstrâdâtas.

Ârstçðana

Sâkot ârstçðanu, vislabâk bûtu pârtraukt antibiotiku lietoðanuvispâr vai aizstât uz tâdâm antibiotikâm, kas mazâk veicinaClostridium difficile proliferâciju: fluorhinolonus (nedrîkst lietotjaunâ patogçniskâ celma gadîjumâ), aminoglikozîdus, trimetoprimu/sulfametoksazolu un nitrofurânus. Nekâdâ gadîjumâ nedrîkst lietotperistaltiku mazinoðus medikamentus, jo tie tikai veicinâs toksînauzkrâðanos zarnâ un tâ iedarbîbu.

Atceïot antibiotikterapiju, caureja izzûd tikai 20% gadîjumu.Tâpçc parasti nepiecieðama papildu specifiska antibiotikterapija.Izvçles medikaments infekcijas ârstçðanâ ir metronidazols, ko

Ar antibiotiku lietoðanu saistîta Clostridiumdifficile infekcijaUga Dumpis,Dr. med., Latvijas Universitâtes Medicînas fakultâtes docents,P. Stradiòa klîniskâs universitâtes slimnîcas infektologs un epidemiologs,Zâïu valsts aìentûras Zâïu blakusparâdîbu uzraudzîbas ekspertu padomes loceklis

vislabâk lietot pa 0, 4 g trîs reizes dienâ iekðíîgi. Vankomicîns pa 125mg èetras reizes dienâ iekðíîgi varçtu bût alternatîva. Vankomicînsir rûgts, tâpçc grûti ieòemams. Vankomicînu varçtu lietot par izvçlespreparâtu intensîvâs terapijas nodaïas pacientiem, kâ arî pacientiemar zemu albumînu koncentrâciju asinîs. Smagas infekcijas gadîjumâabas antibiotikas var lietot vienlaikus, kâ arî palielinât vankomicînadevu. Ârstçðanas kursa ilgumam vajadzçtu bût vismaz desmit dienasvai arî ilgâk, ja efekts rodas vçlu. 5% gadîjumu iespçjams recidîvs,kas jâârstç ar tâm paðâm antibiotikâm. Alternatîvi varçtu lietotfuzidînu, kas paðreiz Latvijâ nav pieejams.

Probiotiku lietoðana nav efektîva, kaut gan tâs var pievienotantibiotikterapijai. Probiotiku efektivitâte Clostridium difficileinfekcijas gadîjumâ pierâdîta tikai gadîjumos, ja tâs lieto profilaksei.

Profilakses pasâkumi

Clostridium difficile slimnîcâ izplatâs epidçmijas veidâ, tâpçctâs izplatîba jâierobeþo ar stingriem infekcijas kontroles pasâkumiem.

Infekcijas kontroles pasâkumi slimnîcâ:l pacienti jâizolç atseviðíâ palâtâ ar atseviðíiem

stetoskopiem, termometriem un asinsspiediena mçrîtâjiem;l personâlam jâlieto cimdi un priekðauti;l personâls jâinformç par infekcijas pârneðanas ceïiem;l palâtâ visas virsmas jâapstrâdâ ar dezinfektantu;l roku mazgâðanai nedrîkst lietot spirtu saturoðos ðíidrumus

(tie neiznîcina sporas), bet tâs jâmazgâ ar antibakteriâlâm ziepçm unjâslauka ar papîra salveti;l rûpîgi jâreìistrç visi jaunie infekcijas gadîjumi.Pagaidâm aktîvi tiek strâdâts ar pasîvâs un aktîvâs imunizâcijas

metodçm ðâs infekcijas novçrðanâ, tomçr pilnîgi pçtîjumi ar cilvçkiemvçl nav veikti.

Vçres

Starr J. Clostridium difficile associated diarrhoea: diagnosis andtreatment. BMJ, 2005, 331: 498-503.Pepin J. et al. Clostridium difficile associated diarrhoea in a region ofQuebeck from 1991 to 2003: a changing pattern of disease severety.CMAJ, 2004; 171: 466-72.Bartlett J G, Perl T M.The new Clostridium difficile�what does itmean? N Engl. J. Med. 2005 Dec 8;353(23):2503-5.Bricker E, Garg R, Nelson R, Loza A, Novak T, Hansen J. Antibiotictreatment for Clostridium difficile-associated diarrhea in adults(Cochrane Review). In: The Cochrane Library, Issue 1, 2006. Chichester,UK: John Wiley & Sons, Ltd..Dendukuri N, Costa V, McGregor M, Brophy JM. Probiotic therapy forthe prevention and treatment of Clostridium difficile-associateddiarrhea: a systematic review. CMAJ. 2005 Jul 19;173(2):167-70.Review. Erratum in: CMAJ. 2005 Aug 16;173(4):345.

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Arvien pieaugoðâ mikroorganismu rezistence pretmedikamentiem kïuvusi par nozîmîgu mûsdienu medicînasproblçmu (5, 8, 12).

Primârâ un sekundârâ mikroorganismurezistence

Mikroorganismu rezistence pret antibakteriâliem (antimikrobiskiem)*preparâtiem ir konkrçtas mikroorganismu sugas nejutîgums pretmedikamentu.

Daïai mikroorganismu tâ ir dabiska îpaðîba, jo antibakteriâliepreparâti nav universâli, tie darbojas tikai pret noteiktâm mikroorganismugrupâm.

Citâdi ir ar mikroorganismu iegûto rezistenci. Jau íîmijterapijassâkumos novçroja, ka mikroorganismi, kas sâkumâ bija jutîgi pretpreparâtu, ar laiku jutîgumu zaudçja.

Íîmijterapijas pamatlicçjs Pauls Çrlihs 19. gadsimta beigâs ieguvapirmos antibakteriâlos preparâtus � tie bija arsçna preparâti prettripanosomozi. Pçc neilgas preparâtu lietoðanas Çrlihs konstatçjarezistentus tripanosomu celmus.

Sâkoties antibiotiku çrai 20. gadsimta 40. gados, pret tâm sâkâs arîintensîva mikroorganismu rezistences veidoðanâs. Lîdz pat mûsu dienâmmikroorganismu rezistence turpina veidoties un izplatîties ar pieaugoðuintensitâti un kïuvusi par vienu no mûsdienu medicînas aktuâlajâmproblçmâm, kam tiek veltîts daudz pçtîjumu.

Mikroorganismu rezistences iedalîjums

Primârâ rezistence ir mikroorganismu dabiska îpaðîba. Tâ varsaistîties

1) ar mçría trûkumu mikroorganisma ðûnâ � tas nozîmç, kapreparâtam nav uz ko iedarboties, tâ, piemçram, mikoplazmâm nav ðûnassienas, tâpçc uz tâm nevar darboties ðûnas sienas inhibitori;

2) ar degradçjoðu enzîmu sintçzi, piemçram, daudzas gramnegatîvasbaktçrijas producç β laktamâzes, kas sagrauj β laktâma gredzenu;

3) mikroorganisma citoplazmatiskâs membrânas (CM) poru lielumsneïauj caur to iekïût medikamenta molekulâm, it îpaði ja tâs ir lielas unzarotas.

Sekundârâ rezistence ir iegûta, tâ mikroorganismu pasaulç radâstikai pçc tam, kad cilvçki sâka lietot pretmikrobu preparâtus.

Rezistences veidoðanas spçja daþâdâm mikroorganismu sugâm irdaþâda. Viens no raksturîgiem âtras rezistences veidoðanas piemçriemir stafilokoku rezistence pret penicilîniem. Par penicilîna atklâjçju tiekuzskatîts angïu bakteriologs Aleksandrs Flemings, bet kopð 1928. gada,kad viòð konstatçja penicilîna esamîbu, pagâja 12 gadu, lîdz Florî unÈeins ieguva tîru preparâtu un ieviesa to klîniskâ praksç. Tâtad penicilînaun, vispârinot, antibiotiku çra sâkâs 1941. gadâ. Penicilînam bija neticamiþilbinoði panâkumi. Tas lieliski darbojâs pret virkni mikroorganismu,

Paðizglîtîba

Mikroorganismu rezistence pretantibakteriâliem preparâtiemAija Þilevièa,Latvijas Universitâtes Medicînas fakultâtes profesore

îpaði grampozitîviem kokiem � stafilokokiem, streptokokiem u.c. Tomçrdrîz vien atklâjâs, ka stafilokoki var zaudçt savu sâkotnçjo jutîbu pretmedikamentu.

Tâ, piemçram, jau 1944. gadâ publicçti pirmie ziòojumi, ka izolçtirezistenti stafilokoku celmi, bet 1948. gadâ to daudzums daþâs slimnîcâsjau sasniedza 65 � 85%.

Ïoti âtri noskaidrojâs stafilokoku rezistences mehânisms. Atklâjâs,ka mikroorganismi sâk izstrâdât penicilînu graujoðu fermentu β laktamâzi(penicilinâzi). (2, 3, 4).

Penicilîna struktûras pamatâ ir ciklisks savienojums β laktâmagredzens, ko ferments hidrolizç.

Rûpîgâ darbâ zinâtnieki 1960. gadâ radîja jaunus penicilînu grupaspreparâtus. Tie bija t.s. otrâs paaudzes penicilîni, kas nav jutîgi pret βlaktamâzçm. Pie tiem pieder meticilîns, nafcilîns, oksacilîns. Diemþçl ðoreizmikroorganismu reakcija bija vçl âtrâka � jau tai paðâ gadâ tika izdalîtipirmie meticilînrezistentie stafilokoki. Praksç vairâk lieto terminu�meticilînrezistence�, kaut arî to varçtu saukt par �oksacilînrezistenci�,jo praktiskâ laboratorijâ rezistenci noteic ar oksacilîna diskiem.

Meticilînrezistentie stafilokoki � S. aureus (MRSA) un S.epidermidis grupa jeb koagulâzes negatîvie stafilokoki (MRSE) kïuvuðipar nopietnu problçmu veselîbas aprûpes darbiniekiem. Îpaði nozîmîgitie ir slimnîcâs, jo pieder pie galveniem nozokomiâliem patogçniem. Todaudzums daþâdâs valstîs atðíiras, bet atseviðíâs slimnîcâs intensîvâsterapijas nodaïâs izolâtu ir ïoti daudz un sasniedz pat pusi no visiembakteriçmijas izraisîtâjiem (9, 11).

Ðiem stafilokokiem ir cits rezistences mehânisms � ðûnâ ir mainîtspenicilînu saistoðais proteîns (Penicillin binding protein � PBP).Parasto PBP-2, pie kura piesaistâs β laktâmu antibiotikas, aizstâj mainîtsproteîns, ko apzîmç ar PBP-2a. Tâ veidoðanos noteic mec A gçns jebmec A determinante. Mec A gçns ir lokalizçts lielâ mobilâ ìençtiskâelementâ, ko sauc par stafilokoku hromosomâli kaseti mec ( SCC mec).Bet diemþçl kasetç ïoti bieþi pievienojas vçl citi rezistences gçni, tâpçcmeticilînrezistentie stafilokoki gandrîz vienmçr ir polirezistenti.Polirezistence � parâdîba, kad mikroorganisms kïûst nejutîgs pretvairâkâm medikamentu grupâm. Uzskata, ka par polirezistentu dçvçjamsmikroorganisms, kas ir nejutîgs pret vismaz 2 � 3 antibakteriâlo preparâtugrupâm.

Tâ kâ meticilînrezistentie stafilokoki satur mainîtu penicilînsaistoðoproteînu, neviens no bçta laktâmiem piesaistîties nevar. Tas nozîmç, kamikroorganisms ir nejutîgs pret visiem ðâs grupas medikamentiem.Daþreiz in vitro testos parâdâs jutîba pret kâdu bçta laktâmu, bet tâjâinterpretç par rezistenci. Izvçles preparâti ir glikopeptîdu antibiotikas,galvenokârt vankomicîns. Bet diemþçl pasaulç jau izveidojuðies un cirku-lç vankomicînnejutîgi celmi VRSA (vankomicînrezistentais S. aureus)un VISA (vancomycin-intermediate), kas problçmu padara vçlnopietnâku (1).

Latvijâ darbs MRSA uzraudzîbâ ir tikai aizsâkts. Primârâ diagnostikatiek veikta visâs bakterioloìiskâs laboratorijâs, kamçr apstiprinoðos

* Termins �mikroorganismu rezistence pret antibakteriâliem preparâtiem ir garð un grûti lietojams. Angliski saka: �antimicrobial resistance�, tâdçï arî latviskirunâ par �antimikrobisko rezistenci�. Tomçr ðâdu vârdkopu nevajadzçtu lietot, jo tâ rada pretçju priekðstatu � par rezistenci pret mikroorganismiem.Pieïauju iespçju lietot terminu �antibiotikrezistence�, kaut arî ar zinâmâm iebildçm. Medicînâ lieto ne tikai antibiotikas, bet arî pretmikrobu íîmijpreparâtus,tâdçïpareizâk runât par �antimikrobiskiem preparâtiem�. Termins �antibiotikrezistence� var tikt lietots tikai nosacîti.

Zâïu valsts aìentûra Cito! � 3 (21) 7

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8 Cito! � 3 (21) Zâïu valsts aìentûra

testus veic galvenokârt Stradiòa slimnîcâ, Infektoloìijas centrâ,Traumatoloìijas un ortopçdijas slimnîcâ un vçl daþâs klînikâs.Pakâpeniski tiek veidots rezistences reìistrs. Vankomicîna rezistenceLatvijâ nav reìistrçta.

Rezistences pçtîðana

Rezistenci var analizçt no bioíîmiskâ un ìençtiskâ viedokïa.Pârmaiòas mikrobu ìençtiskajâ informâcijâ (tâ ir cçloòparâdîba) radajaunu bioíîmisku mehânismu ðûnâ, kas nodroðina tâs rezistenci (sekuparâdîba).

Mikroorganismu rezistences bioíîmiskie aspektiIr èetri galvenie bioíîmiskie mehânismi, kas nodroðina baktçriju

rezistenci pret antimikrobiskiem preparâtiem. Lai saprastu ðosmehânismus, jâatceras antimikrobisko preparâtu darbîbamikroorganisma ðûnâ.

1. Graujoðu un modificçjoðu enzîmu izstrâde. Visvairâk pçtîtas irmikroorganismu b laktamâzes, kas sagrauj β laktâma gredzenupenicilînos, cefalosporînos u.c. β laktâmos. Graujoðs efekts ir arîhloramfenikolacetiltransferâzei u.c. enzîmiem. Lai rastos rezistence, nevienmçr nepiecieðams medikamentu sagraut. Pietiek to mainît, modificçt,lai tas nespçtu darboties. Tâ rezistenci nodroðina aminoglikozîdusacetilçjoðie, fosforilçjoðie, adenilçjoðie enzîmi, ko spçj producçtstafilokoki, streptokoki u.c. mikroorganismi.

2. Mainâs �mçríis� ðûnâ, proti, struktûra, receptors, pie kuraantibakteriâlais preparâts piestiprinâs. Tâ, piemçram, meticilînrezistentostafilokoku darbîbas pamatâ ir penicilînu saistoðâ proteîna (PBP) maiòamikroba ðûnâ, kuras dçï antibiotika nevar sâkt darboties.

Lîdzîgs mehânisms darbojas pret proteînu inhibçtâjantibiotikâm.Aminoglikozîdi mikrobu ðûnâ iedarbojas uz 30S ribosomu, tetraciklîni �uz 50S ribosomu. Rezistentâm baktçrijâm ðo ribosomu virsmâ ir mainîtasproteînu apakðvienîbas, tâpçc preparâti nedarbojas. Tâ, piemçram, 30Sribosomu virsmas receptors ir olbaltums P12, kas spçj mainît savustruktûru un tâdçjâdi nodroðinât rezistenci pret streptomicînu.

Var bût arî cits mehânisms. Eritromicîns saistâs pie 50S ribosomu23S RNS. Baktçrijas aizsargâjas, producçjot RNS-metilâzi,kas maina RNSun rada rezistenci pret antibiotiku.

3. Baktçrijas spçj mainît citoplazmatiskâs membrânas (CM) porucaurlaidîbu, neielaiþot ðûnâ nevçlamas vielas no vides, arî antibakteriâlospreparâtus. Poras var bût arî pavisam slçgtas. Ðis ir funkcionâls, îslaicîgs

mehânisms, bet jâatceras, ka daudzas gramnegatîvâs baktçrijas toizmanto, tâdçï svarîgi ir ievçrot terapijas kursa ilgumu, lai baktçrijasaizietu bojâ.

CM ir mikrobu ðûnas selektîvâs caurlaidîbas regulçtâjs. Bez porulieluma maiòas te darbojas arî speciâli proteîni, kas spçj selektîvi izvadîtkaitîgas molekulas, ja tâs iekïuvuðas ðûnâ. To sauc par sûkòamehânismu. Tâ tiek izvadîti arî antibakteriâlie preparâti.

Lîdzîgas regulâcijas sistçmas darbojas arî citâs dzîvâs sistçmâs,piemçram, cilvçka ïaundabîgâs ðûnâs, kas izvada medikamentus u.c.

4. Mikroorganismi spçj mainît savas bioíîmiskâs reakcijas un izslçgtno aprites pret antibakteriâlu preparâtu jutîgu bioíîmisko íçdi. Viens nomçríiem, pret ko vçrðas medikamenti, piemçram, íîmijpreparâtitrimetoprims, sulfonamîdi, ir folijskâbes sintçze.

Sulfonamîdi inhibç fermentu dihidropteroâtsintetâzi, kas darbojasfolijskâbes sintçzç. Lai izdzîvotu, baktçrijas ðo íçdi aizstâj ar citu uncitiem fermentiem, kas ir nejutîgi pret preparâtiem.

Mikroorganismu rezistences ìençtiskie aspektiPirms sâkt analizçt mikroorganismu rezistences ìençtiskos

mehânismus, jâatzîmç, ka, lai gan reti, tomçr sastopama arî neìençtiskârezistence. Tas nozîmç, ka tâ nav saistîta ar genoma pârmaiòâm, tâtadnav stabila. Pirmkârt, tas var bût saistîts ar �mçría� pârmaiòâm. Parâdâsfenotipiski mikroorganismu varianti, kuros izzudis �mçríis�, uz kodarbojas antimikrobiskais preparâts.

Tas var notikt, piemçram, ja baktçrija pâriet L formâ. Ðai gadîjumâ tâzaudç ðûnas sienu, un ðûnas sienas inhibitori nevar darboties.

Otrkârt, neìençtiskâ rezistence var rasties mikroorganismumetabolisma neaktivitâtes dçï. Vairums preparâtu ietekmç metaboliskiaktîvus mikroorganismus. Ja mikroorganisms kïûst persistçjoðs,�snaudoðs�, bez aktîva metabolisma un dalîðanâs, arî tad antimikrobiskipreparâti nevar darboties. To novçro tuberkulozes gadîjumâ armikobaktçrijâm u.c. Bet, kâ jau minçts, fenotipiskâ mainîba unneìençtiskâ rezistence nav pastâvîga, tâ ir îslaicîga un, apstâkïiemmainoties, izzûd.

Ìençtiskâ rezistence saistîta ar noteiktu rezistences gçnu darbîbu,kuri var bût lokalizçti vai nu baktçrijas genomâ (hromosomâ), vai arîekstrahromosomâlâ ìençtiskâ elementâ.

Tâtad ìençtiskajâ aspektâ mikroorganismu rezistence var bûthromosomâla un ekstrahromosomâla. Tas nozîmç, ka vai nu mainâsgenoma gçni un to ekspresija, vai mikroorganisms iegûst papilduìençtisko informâciju, t.s. ekstrahromosomâlo DNS.

Turpinâjums sekos

Saskaòâ ar British Medical Journal sniegto informâciju pirmajâklîniskajâ pçtîjumâ ar raþotâjsabiedrîbas TeGenero preparâtu TGN 1412(monoklonâla antiviela) 6 pçtîjuma dalîbniekiem, kas saòçma TGN 1412,attîstîjâs multipla orgânu mazspçja. Tâpçc ir pamats vçrtçt pârmaiòunepiecieðamîbu pçtîjumu dizainâ un aktualizçt medicîniskâs izpçtesatklâtîbu.

TGN 1412 pçtîjumu, kurâ paredzçta pakâpeniska dozçðana, atïâvaLielbritânijas Zâïu un veselîbas aprûpes produktu aìentûra (MHRA).Tomçr MHRA pârstâvji atklâja, ka pakâpenisko dozçðanu nepiemçrolîdz pat 80% I fâzes pçtîjumu, jo lietotâ deva bijusi pat 500 reiþu mazâkapar to, kas dota pçtîjumos ar dzîvniekiem. Profesors Dþo Koljers (JoeCollier) no Svçtâ Jura slimnîcas medicînas skolas (Londona) uzskata,ka bijis neprâts iepriekð cilvçkam nepârbaudîtu preparâtu dot vienlaikusvairâkiem cilvçkiem. Profesors uzsver, ka risks, kas saistîts ar jaunasgrupas preparâta lietoðanu pirmo reizi, mazinâtos, ja preparâtu sâkumâdotu vienam cilvçkam un novçrotu tâ iedarbîbu. Un tikai pçc tam dotu

Zâïu klîniski pçtîjumi

TGN 1412: jâmâcâs no kïûdâmnâkamiem. Ðis bezprecedenta gadîjums liecina arî par to, ka I fâzespçtîjumi jâveic vietâs, kur var âtri sniegt neatliekamo palîdzîbu.

Þurnâla ievadrakstâ docente Miðela Gudjiera (Michael Goodyear)no Dalhausas universitâtes Halifaksâ (Jaunskotija, Kanâda) uzskata:�Ðî traìçdija rada nepiecieðamîbu pçc atklâtîbas kultûras medicîniskajâizpçtç. Kultûras, no kuras daudzi baidâs un kura arvien vairâk zaudçsavu vietu�. Viòa ierosina, ka monoklonâlu antivielu (CD28) izpçtei arcilvçkiem nekavçjoties jâpiemçro moratorijs, lîdz iespçjamais kaitçjumsir labâk izprasts.

MHRA vada TGN 1412 gadîjuma izmeklçðanu, kuras laikâ noskaidros,vai apstiprinâtâs procedûras tika ievçrotas, kâ arî analizçs iespçjamozâïu mijiedarbîbu vai neatbilstoðu dozçðanu.

VçreReactions 1 Apr 2006 No.1095

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Nelegâlâs zâles uzskatâmas par nemitîgi pieaugoðu draudusabiedrîbas veselîbai. Tas it îpaði sakâms par viltotâm zâlçm, reìistrçtoproduktu kloniem un nereìistrçtâm zâlçm, kas tiek tirgotas kâ tautasdziedniecîbas lîdzekïi, kosmçtika un uztura bagâtinâtâji. Viltotu vai zemaskvalitâtes aktîvo vielu klâtieni iespçjams konstatçt arî reìistrçtosproduktos, kas var izraisît neprognozçjamus draudus. Nelegâlâs zâlesvar izraisît neparedzamu reakciju, blaknes vai iedarbîbu kombinâcijâ arcitâm vielâm. Tâdçï ârstniecîbas darbiniekiem jâòem vçrâ iespçja, kaviens no pacientam konstatçto simptomu iemesliem varçtu bût arînelegâlu zâïu lietoðana.

Viltotas zâlesProduktu viltoðana mûsu dienâs kïuvusi par plaði izplatîtu parâdîbu,

kuras nostiprinâðanos veicina valstis, kas neatzîst patentus. Turklâtglobalizâcijas laikmetâ ðî parâdîba aptvçrusi visu pasauli. Tâdu produktukâ kompaktdisku, apìçrbu un pulksteòu viltoðana ir ekonomiska unjuridiska problçma, ar ko jârçíinâs patenta, preèu zîmes, zîmola vai citaintelektuâlâ îpaðuma tiesîbu turçtâjam. Taèu, viltojot automobiïu detaïas,lidmaðînu komplektçjoðos elementus un farmaceitiskos produktus, tiekapdraudçts automobiïa, lidmaðînas vai zâïu lietotâjs, jo viltojumi bieþivien ir sliktâkas kvalitâtes nekâ oriìinâlprodukti. Tâdçjâdi viltotâs zâlesuzskatâmas par apdraudçjumu sabiedrîbas veselîbai.

Uz viltoto zâïu iesaiòojuma vai maríçjuma tiek sniegta nepatiesainformâcija par to izcelsmi vai sastâvu. Viltotâs zâles uzskatâmas par ïotibûtisku problçmu jaunattîstîbas valstîs. Reìistrçti arî vairâki gadîjumi,kad pçc viltotu zâïu lietoðanas iestâjusies pacienta nâve. Piemçram, pirmsvairâkiem gadiem Haiti bojâ gâja aptuveni 100 bçrnu, kuru ârstçðanâ tikaizmantots preparâts, kas gatavots no viltota glicerîna � patiesîbâ antifrîza.Ðâdiem gadîjumiem nevajadzçtu notikt attîstîtajâs valstîs. Tomçr pat valstîsar droðiem un stingri kontrolçtiem zâïu izplatîðanas tîkliem pacienti daþkârtvar iegâdâties viltotas zâles. Ja pacienti iepçrkas legâlâ aptiekâ vaimedikamentu izplatîðanas tîkla iestâdç, viltotu zâïu iegâdes risks ir ïotineliels. Saskaòâ ar Vâcijas federâlâs policijas sniegto informâciju katrugadu legâlâ medikamentu izplatîðanas tîkla iestâdçs tiek atklâtas aptuveniseðas viltotas zâles. Parasti tie ir oriìinâlprodukti, kam nelegâli nomainîtsiesaiòojums vai maríçjums, kas tâdçjâdi nevar apdraudçt pacientu droðîbu.Tiesa, nesen atrastu antibiotiku, kam bija nelegâli mainîts maríçjums,iedarbîbas potenciâls sasniedza tikai pusi norâdîtâ � ðai gadîjumâ ne tikaiârstçðana var bût neefektîva, bet arî pastâv risks, ka veidosies rezistencepret attiecîgajâm antibiotikâm.

Aptiekas, kas darbojas internetâ un piegâdâ medikamentus pa pastu,papildina esoðo zâïu izplatîðanas tîklu. Ja to darbîba ir legâla un notiekkontrolçjoðâs institûcijas uzraudzîbâ, problçmâm nevajadzçtu rasties.Taèu ðíiet, ka vairums interneta aptieku un medikamentus piedâvâjoðomâjaslapu darbojas nelegâli. Tâs pârdod recepðu zâles bez receptes,piedâvâ nereìistrçtas zâles, kâ arî var piegâdât viltotus un neatbilstoðaskvalitâtes produktus. Tâdçjâdi apdraudçta ir veselîba pacientiem, kasiegâdâjas zâles no nelegâliem vai nezinâmiem avotiem. Piemçram, kâdsjauns vîrietis Vâcijâ gandrîz gâja bojâ, lietojot interneta mâjaslapâ iegâdâtuanalgçtiku, kuras sastâvâ tika konstatçts ïoti spçcîgs sedatîvs lîdzeklis.

Apdraudçjums palielinâs gadîjumos, kad cilvçki medikamentusiegâdâjas melnajâ tirgû. Daþâdiem melnâ tirgus segmentiem ir daþâdasîpatnîbas. Vâcijâ visbîstamâkâ un sareþìîtâkâ situâcija melnajâ tirgû saistîtaar anaboliskâm zâlçm, ko galvenokârt izmanto kultûrisma un smagatlçtikas

Speciâli Cito!

Nelegâlâs zâlesDîtrihs Ðnçdelbahs (Dietrich Schnädelbach),Dr., Federâlais zâïu un medicînas iekârtu institûtsBonna, Vâcija

piekritçji un nelegâli tirgo vingroðanas zâlçs un sporta klubos. Pirmsvairâkiem gadiem Vâcijas policija saskârâs ar kâdu nopietnu gadîjumu,kura izmeklçðanâ tika noskaidrots, ka melnajâ tirgû piedâvâtâs anaboliskâszâles ir zemas kvalitâtes viltojumi. Iepriekð minçtajâ gadîjumâ zâles tikapârbaudîtas un analizçtas Oficiâlajâ zâïu kontroles laboratorijâ. Neviensno pârbaudîtiem paraugiem neatbilda maríçjuma informâcijai. Visas viltotâszâles saturçja vai nu citas aktîvâs vielas, vai arî mazâk aktîvas vielas, nekânorâdîts maríçjumâ. Vairâkos gadîjumos maríçjumâ norâdîtâ aktîvâ vielabija aizstâta ar citu aktîvo vielu kombinâciju, vai arî otrâdi � aktîvo vielukombinâcija bija aizstâta ar vienu aktîvo vielu. Iepriekð minçtâ izmeklçðanaskâra ne tikai Vâciju, bet pavisam 13 Eiropas valstis. Tâdçï varam uzskatît,ka stâvoklis melnajâ tirgû saistîbâ ar anaboliskajâm zâlçm ir lîdzîgs visâEiropâ.

Visi kultûristi un smagatlçti izmanto somatropînu. Vâcijas melnajâtirgû tikuði konstatçti arî zemas kvalitâtes somatropîna viltojumi. Pastâvçjapieòçmums, ka viens no viltotiem produktiem gatavots no somatropîna,kam beidzies derîguma termiòð. Citas partijas produkts saturçja nevissomatropînu, bet gan hCG (horijgonadotropînu). Savukârt vçl kâds citsprodukts, kas tika konstatçts kâdâ vingroðanas zâlç, piesaistîja lieluuzmanîbu un radîja krietnu satraukumu, jo bija iegûts no cilvçka dziedzeriemun tâdçjâdi padarîja iespçjamu Kreicfelda-Jâkoba slimîbas (CJD)pârneðanas risku. Turklât, ðis konkrçtais produkts nebija viltots, bet ganzâles, kas ir reìistrçtas atseviðíâs valstîs.

Prostitûcijas, seksa pakalpojumu jeb tâ sauktie �sarkano lukturu�kvartâli radîjuði piemçrotu augsni, kur var attîstîties un paplaðinâtiessildenafila un lîdzîgu produktu melnais tirgus. Ðai melnajâ tirgû nonâkmodificçtas oriìinâlzâles, viltotas zâles un reìistrçto zâïu kloni. Atseviðíosgadîjumos viltojumu kvalitâte ir pieòemama, taèu pastâv arî izòçmumi �ðo zâïu kvalitâte ir neatbilstoði zema. Ðâs zâles izraisa ïoti specifiskuapdraudçjumu, jo aktîvo vielu daþâdâ koncentrâcija var radît pârdozçðanu,ja patçrçtâjs, kas pieradis preparâtu lietot lielâkâ apjomâ, nejauði iegâdâjasun uzòem viltotas zâles, kuru sastâvâ ir neparedzçti daudz aktîvâs vielas.

KloniMelnajâ tirgû, kur pârdod sildenafilu un citus PD5 inhibitorus, nonâk

arî ðo reìistrçto zâïu kloni. Kloni nav zâïu viltojumi, bet gan to aizstâjçji,kas vairâk vai mazâk var atgâdinât oriìinâlzâles. Piemçram, zâlçm Viagraizstrâdâti kloni, kuru nosaukumi ir Siagra, Diagra u.t.t. Kloni to izcelsmesvalstî, piemçram, Indijâ, var bût gan reìistrçti, gan nereìistrçti. Daþi noðiem kloniem izraisa specifiskas problçmas, jo to sastâvâ ir citkârt nezinâmukombinâciju aktîvâs vielas. Piemçram, reìistrçtu zâïu klonos konstatçtisildenafila un tadalafila kombinâcija. Turklât klonu sastâvâ var ietilpt aktîvâsvielas, kas ir lîdzîgas reìistrçtiem PD5 inhibitoriem, bet ar mainîtumolekulârstruktûru. Pastâv pamatotas aizdomas, ka nedz lîdz ðimnezinâmâs aktîvo vielu kombinâcijas, nedz arî vielas ar mainîtomolekulârstruktûru nav klîniski pârbaudîtas. Ðâ iemesla dçï pastâv risks,ka ðo zâïu lietoðanas dçï gaidâmas neprognozçjamas sekas.

Tâpat kâ gadîjumâ ar viltojumiem, klonu kvalitâte var bût ganpieòemama, gan nepieòemama. Jebkurâ gadîjumâ jâòem vçrâ, ka ðîs zâlesvar nebût gatavotas saskaòâ ar labas raþoðanas prakses nosacîjumiem.Nesen konstatçti gadîjumi, kad klonu produktu sastâvâ aktîvâs vielaskoncentrâcija veido 150% no maríçjumâ norâdîtâs. Ðâdi preparâti varizraisît pârdozçðanu, îpaði, ja ðo paðu zâïu iepriekðçjâ partijâ aktîvâs vielaskoncentrâcija bijusi mazâka nekâ uz iesaiòojuma vai maríçjumâ norâdîtâ.

Zâïu valsts aìentûra Cito! � 3 (21) 9

Page 10: Saturs Bßtiska informâcija

10 Cito! � 3 (21) Zâïu valsts aìentûra

Reìistrçto produktu klonus bieþi piedâvâ internetâ, kur tie tiek reklamçtipar daudz labâkiem medikamentiem nekâ oriìinâlie. Ðie apgalvojumi varbalstîties uz faktu, ka reìistrçto zâïu klons tiek piedâvâts citâs formâs,piemçram, pastilas vai gela veidâ.

Citas nelegâlâs zâlesAizvien vairâk cilvçku tradicionâlo íînieðu medicînu uzskata par

saudzçjoðâku un vieglâku alternatîvu Rietumu medicînai, jo tajâ tiekizmantoti augu valsts materiâli, minerâli un dzîvnieku izcelsmes produkti.Taèu mûsu dienâs ðais zâlçs aizvien bieþâk tiek konstatçtas uz toiesaiòojuma vai maríçjumâ nenorâdîtas vielas. Tâdçï zâles, kuru sastâvâpçc iesaiòojuma vai maríçjuma informâcijas ir tikai augu valsts vielas,daþkârt izmanto, lai ârstçtu, piemçram, diabçtu, reimatismu vai erekcijastraucçjumus. Ðîs zâles tik tieðâm mçdz bût iedarbîgas, jo to sastâvâ varbût glibenklamîds, kortikosteroîds vai sildenafils. Tâ kâ pacients nezinalietojamo zâïu patieso sastâvu, atbilstoðas devas noteikðana irneiespçjama, jo aktîvâs vielas nav norâdîtas. Bez tam arî daþâdâs zâïupartijâs var atðíirties aktîvâs vielas koncentrâcija. Tas skaidrojams arfaktu, ka ðîs zâles bieþi vien tiek piedâvâtas kapsulâs, kur augu valstsmateriâli tiek sajaukti ar íîmiskâm vielâm, un ðâds maisîjums ne vienmçr irnoturîgs un viendabîgs, jo parasti íîmiskâs vielas daïiòas ir daudz mazâkasnekâ augu materiâla daïiòas, kas mçdz atdalîties. Ja atdalîðanâs notieklaikâ, kad maisîjums tiek iepildîts kapsulâs,var gadîties, ka daþâs no tâmnonâk gandrîz tîra íîmiskâ viela, bet citâs � tikai augu materiâls. Ðâdapreparâta iedarbîba var bût tik atðíirîga, ka tas kïûst nepiemçrots ârstçðanâ.Papildus jânorâda, ka aktîvâs vielas izmantoðana kopâ ar augu materiâliemvar izraisît neprognozçjamu mijiedarbîbu un blaknes.

Atseviðíos gadîjumos kosmçtikas lîdzekïus var ieteikt tâdu slimîbukâ psoriâzes ârstçðanai. Ja ðo kosmçtikas lîdzekïu sastâvâ ir glikokortikoîdi,tie patiesi var palîdzçt, taèu ðâdi produkti ir nelegâli. To nosaukumi varietvert vârdus, kas norâda uz indikâciju. Tâ kâ aktîvâ viela netiek norâdîtauz iesaiòojuma vai produkta maríçjumâ, patçrçtâji nezina izmantotâ lîdzekïasastâvu un uzskata, ka atklâjuði labu alternatîvu vispâratzîtai ârstçðanai.Ja attiecîgâs uzraudzîbas iestâdes atklâj, ka ðâdi produkti nonâkuði tirgû,tâs uzliek par pienâkumu raþotâjam atsaukt attiecîgo produktu partijas unaizstât ar lîdzekïiem, kuru sastâvâ nav aktîvâs vielas. Ðâdos gadîjumosdaudzi pacienti jutîs slimîbas uzliesmojumu. Tâ kâ nedz pacienti, nedzviòu ârsti nav informçti par visiem apstâkïiem, tas var radît apjukumu unneizpratni.

Uztura bagâtinâtâji ir viens no produktiem, ko arî var nelegâli piedâvâtslimîbu ârstçðanâ. To iedarbîgums skaidrojams ar tâm paðâm neatïautajâmmetodçm, kas tiek izmantotas �uzlabotu� tradicionâlo íînieðu zâïugadîjumâ. Taèu uztura bagâtinâtâju izmantoðanai var bût arî citasneprognozçjamas sekas. Daþi ðo produktu raþotâji gatavo gan legâlusuztura bagâtinâtâjus, kuru sastâvâ ir vitamîni, gan arî nelegâlusizstrâdâjumus, ko viòi dçvç par uztura bagâtinâtâjiem � tie satur anaboliskasvielas un tiek izmantoti par dopingu. Abi ðie preparâtu veidi parasti pieejamikapsulu veidâ. Tâ kâ ðo produktu gatavotâjiem nav jâievçro labasraþoðanas prakses nosacîjumi un prasîbas, pastâv iespçjas, ka preparâturaþoðanâ izmantotâs iekârtas netiek iztîrîtas, pârtraucot viena medikamentaun sâkot otra apstrâdi. Ja tâ notiek, vienâ preparâtâ izmantotâ aktîvâ vielavar nonâkt cita izstrâdâjuma sastâvâ. Nejauða anabolisko zâïu klâtieneuztura bagâtinâtâjos ir galvenais iemesls, kura dçï anabolisko vielu(dopinga) pârbaudes uzrâda apstiprinoðu rezultâtu sportistiem, kaslietojuði attiecîgos produktus.

Viltotas un zemas kvalitâtes aktîvâs vielasDaþkârt tirgotâji maina aktîvo vielu iesaiòojumu vai maríçjumu. Ðâdas

rîcîbas pamatâ var bût uzòçmçju vçlme aizsargât savu biznesu. Taèuiesaiòojuma vai informâcijas maiòu var izmantot arî nelegâliem mçríiem,piemçram, lai izvairîtos no muitas nodevâm vai nodokïiem. Saskaòâ arpaðreiz spçkâ esoðiem likumiem un normatîviem iesaiòojuma un maríçjumamaiòa tiek uzskatîta par vienu no raþoðanas posmiem, tâpçc tirgotâji arpilnâm tiesîbâm var pretendçt uz raþotâja statusu un norâdît savu

nosaukumu uz iesaiòojuma. Tiesa, daþâs valstîs, to vidû arî ASV, ðâdarîcîba tiek uzskatîta par zâïu viltoðanu. Eiropas Savienîbas kontroles unpârraudzîbas iestâdes uzliek par pienâkumu tirgotâjam norâdît aktîvâsvielas patieso izcelsmi. Tas ir nepiecieðams, jo pretçjâ gadîjumâ bûtuneiespçjami atsaukt un izòemt no apgrozîbas atseviðías produktu partijas,kuru sastâvâ esoðâs aktîvâs vielas izraisa bûtiskas problçmas.

Pirms vairâkiem gadiem bojâ gâja 66 amerikâòi, kuru nâvi izraisîjaneatbilstoðas kvalitâtes gentamicîns. Kâdâ Íînas uzòçmumâ gatavotâgentamicîna kvalitâte bija neatbilstoða parenterâlai izmantoðanai tâ augstâtoksiskuma lîmeòa dçï. Neraksturîgi augsto toksiskuma lîmeni varçja izraisîtfermentâcija, un radusies neatbilstîba netika novçrsta turpmâkajâ vielasattîrîðanâ. Tâ kâ par augstu toksiskuma lîmeni izraisoðiem piemaisîjumiembieþi nekas nav zinâms, tie raþoðanas procesâ var palikt nepamanîti unnonâkt gatavojos produktos. Vienîgâ toksiskuma lîmeòa pârbaudeiespçjama, veicot eksperimentu ar dzîvniekiem. Eiropas raþotâji apgalvo,ka stingri kontrolçtâs fermentâcijas un attîrîðanas dçï ðî problçma vairsnav vçrojama, tâpçc arî pârbaudes ar dzîvniekiem nav nepiecieðamas.Balstoties uz minçto nostâju, pârbaudes ar dzîvniekiem izslçgtas no Eiropasfarmakopejas priekðrakstiem. Iepriekðminçtais gadîjums raksturoja to, kaEiropas raþotâju kvalitâtes standarti ne vienmçr tiek izmantoti citâspasaules daïâs. Ðis fakts jâpatur prâtâ, jo liela daïa Eiropâ izmantotoantibiotiku paðreiz tiek izgatavotas Íînâ un Indijâ.

Aprakstîtais gadîjums ar gentamicînu norâda, ka aktîvâs vielas kvalitâteun nekaitîgums atkarîgi no raþoðanas procesa. Lai arî tâdas nopietnasproblçmas kâ bûtiski paaugstinâts toksiskuma lîmenis atseviðíâmprodukta partijâm nav bieþa parâdîba, zinâms risks pastâv gadîjumos,kad medikamentu raþotâjs pieòem lçmumu par aktîvâs vielas piegâdâtâjamaiòu, tâpçc ðai procesâ jâizmanto atbilstoði kontroles mehânismi. Obligâtinepiecieðama jaunâ piegâdâtâja pârbaude, pârliecinoties par attiecîgâsaktîvâs vielas raþoðanâ un kvalitâtes kontrolç izmantoto priekðrakstuatbilstîbu. Ðâdas pârbaudes, visticamâk, nenotiks gadîjumos, ja tirgotâjsvienu raþotâju nomaina pret citu, nenoskaidrojot aktîvâs vielas patiesoizcelsmi, jo papildu kontroles pasâkumi var palielinât produkta izmaksas.Ðâdos gadîjumos tirgotâja klienti nesâk aktîvas darbîbas, jo vairumâgadîjumu arî tie nav informçti par pârmaiòâm.

Eiropas farmakopejas priekðraksti tika izstrâdâti, pieòemot, kaattiecîgâs aktîvâs vielas gatavo Eiropâ. Augsto raþoðanas izmaksudçï liela daïa aktîvo vielu vairs netiek gatavotas Eiropâ, bet gan ievestasno Íînas un Indijas. Ðo vielu gatavoðana var balstîties uz citâmtehnoloìijâm, instrukcijâm vai izejvielâm. Tâpçc aktîvajâm vielâmiespçjamas novirzes no prasîbâm, kas nav minçtas Eiropasfarmakopejas priekðrakstos. Gadîjumâ ar trimetoprimu tika noteikts,ka Íînâ raþotâs aktîvâs vielas sastâvâ ir 1 � 3% neatbilstoðupiemaisîjumu, ko nav iespçjams noteikt, izmantojot Eiropasfarmakopejas priekðrakstus. Attiecîgajâ gadîjumâ jautâjums tikaveiksmîgi atrisinâts, jo piemaisîjumi nebija toksiski. Problçma tikaatrisinâta, izdarot labojumus priekðrakstos, kas ðobrîd paredz visu topiemaisîjumu kontroli, kuru koncentrâcija pârsniedz 0,1%.

Austrâlijâ reìistrçto neraksturîgo petidîna blakòu dçï tikapârskatîts attiecîgais Eiropas farmakopejas priekðraksts. Minçtajâgadîjumâ secinâts, ka petidîna sastâvâ ir toksisks piemaisîjums MFTP(1-metil-4-fenil-1,2,3,6-tetrahidropiridîns), kas netiek kontrolçts arattiecîgâ priekðraksta palîdzîbu. Eiropâ raþotâ petidîna sastâvâ MFTPpiemaisîjumi tika konstatçti tikai ïoti nelielâ koncentrâcijâ, bet,neskatoties uz ðo apstâkli, attiecîgais farmakopejas priekðraksts tikalabots, lai kontrolçtu MFTP pat tad, ja tâ lîmenis nav augsts unuzskatâms par nekaitîgu. Turklât attiecîgais vâcu raþotâjs mainîjasintçzes tehnoloìiju un tâdçjâdi produktâ vispâr vairs nebijakonstatçjamas MFTP pçdas. Ðis gadîjums parâda, ka ne tikaifermentçðanâ, bet arî íîmiskâ sintçzç var rasties ïoti toksiskipiemaisîjumi. Gadîjums ar L-triptofânu parâdîja, ka pat attîrîðanaspârmaiòas var bûtiski mazinât vielas nekaitîgumu. Tâdçï pacientiem,novçrojot neparedzçtas vai jaunas blaknes, jâpârbauda problçmasiespçjamâ saistîba ar aktîvâs vielas sintçzi un attîrîðanu vai piegâdâtâjamaiòu.

Page 11: Saturs Bßtiska informâcija

Ârstniecîbas lîdzekïa nosaukums, Starptautiskais Zâïu reìistrâcijas Farmakotera- ATÍ kods Reìistrâ- Izplatîðanazâïu forma un dozçjums nosaukums apliecîbas îpaðnieks peitiskâ grupa cijas Nr.

Agapurin SR 600 mg, Pentoxiphyllinum Zentiva a.s., Slovâkija perifçriskos asinsvadus C04AD03 06-0110 Rpprolonged release tablets paplaðinoðs lîdzeklisBalance 1,5 % glucose, 1,25 mmol/l; Calcii chloridum dihydricum, Fresenius Medical Care peritoneâlâs dialîzes B05DB 06-0070 Rp2,3 glucose, 1,25 mmol/l; 4,25 % Glucosum monohydricum, Deutschland GmbH, Vâcija ðíîdums 06-0071 Rpglucose, 1,25 mmol/l calcium solution Magnesii chloridum 06-0072 Rpfor peritoneal dialysis°, Solution for hexahydricum, Natrii chloridum,peritoneal dialysis Natrii lactatis solutioBalance 1,5 % glucose, 1,75 mmol/l; Calcii chloridum dihydricum, Fresenius Medical Care peritoneâlâs dialîzes B05DB 06-0073 Rp2,3 % glucose, 1,75 mmol/l; 4,25 % Glucosum monohydricum, Deutschland GmbH, Vâcija ðíîdums 06-0074 Rpglucose, 1,75 mmol/l, calcium solution Magnesii chloridum 06-0075 Rpfor peritoneal dialysis°, hexahydricum, Natrii chloridum,Solution for peritoneal dialysis Natrii lactatis solutioBronchicum Elixir S, oral solution Thymi extractum fluidum, A. Nattermann & Cie. atkrçpoðanas lîdzeklis R05CA 06-0078 Bezrecepðu

Primulae radices extractum GmbH, Vâcijafluidum

Bronchicum Syrup S, syrup Thymi extractum fluidum A. Nattermann & Cie. atkrçpoðanas lîdzeklis R05CA 06-0079 BezrecepðuGmbH, Vâcija

Bupivacaine-Grindeks 5 mg/ml, Bupivacaini hydrochloridum AS Grindeks, Latvija vietçjâs anestçzijas lîdzeklis N01BB01 06-0067 Rpðíîdums injekcijâmBupivacaine-Grindeks Spinal 5 mg/ml, Bupivacaini hydrochloridum AS Grindeks, Latvija vietçjâs anestçzijas lîdzeklis N01BB01 06-0068 Rpðíîdums injekcijâmCitalopram-Teva 10 mg; 20 mg; Citalopramum Teva Pharma B.V., antidepresants N06AB04 06-0095 Rp40 mg°, film-coated tablets Nîderlande 06-0096 Rp

06-0097 RpCoffeinum-Natrii benzoas 200 mg/ml, Coffeinum, Natrii benzoas SIA Briz, Latvija CNS stimulators, N06BC01 06-0069 Rpsolution for injection ksantîna derivâtsDolmen 12,5 mg; 25 mg°, Dexketoprofenum Menarini International nesteroidâls pretiekai- M01AE17 06-0080 Rpfilm-coated tablets Operations Luxembourg suma lîdzeklis 06-0081 Rp

S.A., LuksemburgaDolmen 50 mg/2 ml°, solution for injection Dexketoprofenum Menarini International nesteroidâls pretiekai- M01AE17 06-0082 Rpor concentrate for solution for infusion Operations Luxembourg suma lîdzeklis

S.A., LuksemburgaElosalic 0,1 %/5 %°, ointment Mometasoni furoas, Schering-Plough dermatoloìisks lîdzeklis D07XC03 06-0088 Rp

Acidum salicylicum Europe, BeïìijaEpirubicin Mayne 2 mg/ml°, Epirubicini hydrochloridum Mayne Pharma Plc, onkoloìisks lîdzeklis L01DB03 06-0117 Rpsolution for injection LielbritânijaHumaglobin-Elvim 0,5 g; 1 g; 2,5 g; Immunoglobulinum SIA Elvim, Latvija cilvçka normâlais J06BA02 06-0063 Rp5 g powder and solvent for solution for humanum normale imûnglobulîns 06-0064 Rpinfusion, Powder and solvent for solution 06-0065 Rpfor infusion 50 mg/ml 06-0066 RpHuman Albumin-Elvim 5 %, Albuminum humanum SIA Elvim, Latvija plazmas aizstâjçjs B05AA01 06-0062 Rpsolution for infusionKetesse 12,5 mg; 25 mg°, Dexketoprofenum Menarini International nesteroidâls pretiekai- M01AE17 06-0083 Rpfilm-coated tablets Operations Luxembourg suma lîdzeklis 06-0084 Rp

S.A., LuksemburgaKetesse 50 mg/2 ml°, solution for Dexketoprofenum Menarini International nesteroidâls pretiekai- M01AE17 06-0085 Rpinjection or concentrate for Operations Luxembourg suma lîdzeklissolution for infusion S.A., LuksemburgaLozap 12,5 mg; 25 mg; 50 mg; Losartanum Zentiva a.s., Slovâkija antihipertensîvs lîdzeklis, C09CA01 06-0090 Rp100 mg°, film-coated tablets angiotenzîna II receptoru 06-0091 Rp

antagonists 06-0092 Rp06-0093 Rp

Metoject 7,5 mg/0,75 ml; 10 mg/1 ml; Methotrexatum Medac Gesellschaft für folijskâbes antagonists L01BA01 06-0102 Rp15 mg/1,5 ml; 20 mg/2 ml; klinische Spezialpräparate 06-0103 Rp25 mg/2,5 ml solution for injection, mbH, Vâcija 06-0104 Rppre-filled syringe°, Solution for injection, 06-0105 Rppre-filled syringe 10 mg/ml 06-0106 RpNaltrexone aop 50 mg°, Naltrexoni hydrochloridum AOP Orphan opioîdu antagonists V03AB30 06-0108 Rpfilm-coated tablets Pharmaceuticals AG, AustrijaNicotinell Fruit 2 mg; 4 mg°, Nicotinum Novartis Finland Oy, Somija pretsmçíçðanas lîdzeklis N07BA01 06-0113 Bezrecepðumedicated chewing gum 06-0115 BezrecepðuNicotinell Mint 2 mg; 4 mg°, Nicotinum Novartis Finland Oy, Somija pretsmçíçðanas lîdzeklis N07BA01 06-0114 Bezrecepðumedicated chewing gum 06-0116 BezrecepðuOmsal 0,4 mg, prolonged-release capsules Tamsulosini hydrochloridum Gedeon Richter Ltd., Ungârija prostatoterapeitisks lîdzeklis G04CA02 06-0089 RpParoxetin Sandoz 20 mg°, tablets Paroxetinum Sandoz GmbH, Austrija antidepresants N06AB05 06-0107 RpPrimalan 5 mg; 10 mg, tablets Mequitazinum Laboratoires Pierre Fabre prethistamîna lîdzeklis R06AD07 06-0111 Rp

Medicament, Francija 06-0112 RpRelifex 1 g film-coated, tablets Nabumetonum Meda AB, Zviedrija nesteroidâls pretiekai- M01AX01 06-0094 Rp

suma lîdzeklis

Zâïu reìistrs

Izmaiòas Latvijas Republikas Zâïu reìistrâSaskaòâ ar Zâïu valsts aìentûras 03.04.2006. rîkojumu Nr.2 � 20/4 un 28.04.2006. rîkojumu Nr.2 � 20/5

Zâïu reìistrâ iekïautâs zâles

Zâïu valsts aìentûra Cito! � 3 (21) 11

Page 12: Saturs Bßtiska informâcija

12 Cito! � 3 (21) Zâïu valsts aìentûra

Roko 2 mg, capsules Loperamidum SIA Unifarma, Latvija pretcaurejas lîdzeklis A07DA03 06-0061 BezrecepðuSertrabeck 50 mg; 100 mg°, Sertralinum Alfred E. Tiefenbacher antidepresants N06AB06 06-0076 Rpfilm-coated tablets GmbH & Co. KG, Vâcija 06-0077 RpSumatriptan Sandoz 50 mg; Sumatriptanum Sandoz GmbH, Austrija pretmigrçnas lîdzeklis N02CC01 06-0086 Rp100 mg°, tablets 06-0087 RpTamsulosin Lannacher 0,4 mg°, Tamsulosini hydrochloridum Lannacher Heilmittel prostatoterapeitisks G04CA02 06-0109 Rpmodified release capsules, hard Ges.m.b.H., Austrija lîdzeklisUltak 150 mg, coated tablets Ranitidinum SIA Unifarma, Latvija pretèûlas lîdzeklis, A02BA02 06-0099 Bezrecepðu

H2-receptoru blokatorsUltak 300 mg, coated tablets Ranitidinum SIA Unifarma, Latvija pretèûlas lîdzeklis, A02BA02 06-0100 Rp

H2-receptoru blokatorsVitamin B complex, coated tablets Riboflavinum, Thiamini SIA Briz, Latvija vitamînu preparâts A11EX 06-0101 Bezrecepðu

nitras, Pyridoxinihydrochloridum, Nicotinamidum

° Zâles reìistrçtas savstarpçjâs atzîðanas procedûrâ

Ârstniecîbas lîdzekïa nosaukums, zâïu Starptautiskais nosaukums Zâïu reìistrâcijas Farmakotera- ATÍ kods Reìistrâ- Izplatîðanaforma un dozçjums apliecîbas îpaðnieks peitiskâ grupa cijas Nr.

Acivir 200 mg; 400 mg, tablets Aciclovirum Cipla (UK) Limited, pretvîrusu lîdzeklis J05AB01 01-0143 RpLielbritânija 01-0144 Rp

Aminazîns 25 mg/ml, ðíîdums injekcijâm Chlorpromazini hydrochloridum A/S �Kalceks�, Latvija neiroleptisks lîdzeklis N05AA01 95-0357 RpAminoplasmal Hepa-10 %, Isoleucinum, Leucinum, Lysini B.Braun Melsungen AG, parenterâlâs baroðanas B05BA01 96-0121 Rpsolution for infusion acetas, Methioninum, Vâcija lîdzeklis

Phenylalaninum, Threoninum,Tryptophanum, etc.

Arnikas 5 % ziede ar E vitamînu Tocopheroli acetas, Arnicae SIA �Natur Produkts�, Latvija dermatoloìisks lîdzeklis D11AX 01-0050 Bezrecepðubiðu vaskâ, Ziede flos extractum fluidum,

Beta CarotinumASS gamma 75 mg, tablets Acidum acetylsalicylicum Wörwag Pharma GmbH & antitrombotisks lîdzeklis B01AC06 01-0237 Bezrecepðu

Co.KG, VâcijaBepanthen 5 %, ointment Dexpanthenolum Bayer Oy, Somija dermatoloìisks lîdzeklis D03AX03 96-0058 BezrecepðuBetnovate Ointment, 0, 1 %, ointment Betamethasonum GlaxoSmithKline Latvia kortikosteroidâls, D07AC01 01-0207 Rp

SIA, Latvija dermatoloìisks lîdzeklisBudenofalk 3 mg, capsules Budesonidum Dr. Falk Pharma GmbH, Vâcija kortikosteroidâls A07EA06 00-1222 RpCalcigran Forte 500 mg/400 IU, Cholecalciferolum, Calcium Nycomed Pharma AS, kalcija preparâts A12AX 01-0136 BezrecepðuChewable tablets NorvçìijaCelebrex 100 mg; 200 mg, capsule, hard Celecoxibum Pfizer Limited, Lielbritânija nesteroidâls M01AH01 01-0288 Rp

pretiekaisuma lîdzeklis 01-0289 RpCelestoderm-V 0, 1 %, Cream Betamethasonum Schering-Plough Europe, kortikosteroidâls, D07AC01 01-0065 Rp

Beïìija dermatoloìisks lîdzeklisCelestoderm-V 0, 1 %, Ointment Betamethasonum Schering-Plough Europe, kortikosteroidâls, D07AC01 01-0066 Rp

Beïìija dermatoloìisks lîdzeklisCerebrum compositum NM, Cerebrum suis, Embryo suis, Biologische Heilmittel homeopâtisks lîdzeklis V03AX 00-1093 Rpsolution for injection Hepar suis, Placenta suis, Heel GmbH, Vâcija

Kalium phosphoricum,Selenium, Thuja occidentalis,Ignatia, etc.

Coenzyme compositum solution for Coenzymum A, Acidum Biologische Heilmittel Heel homeopâtisks lîdzeklis V03AX 01-0112 Rpinjection, Solution for injection ascorbicum, Thiamini GmbH, Vâcija

hydrochloridum, Natriiriboflavinum phosphoricum,Pyridoxini hydrochloridum, etc.

Deep Freeze Spray, Spray Levomentholum, N-Penthanum The Mentholatum Company pretsâpju lîdzeklis M02AX 00-1096 BezrecepðuLimited, Lielbritânija

Deviòvîru spçka 20 % ziede ar E Tocopheroli acetas, Verbasci SIA �Natur Produkts�, Latvija dermatoloìisks lîdzeklis D11AX 01-0102 Bezrecepðuvitamînu biðu vaskâ, Ointment 20 % flos extractum fluidumDexona 4 mg/ml, solution for injection Dexamethasonum Zydus France SAS, Francija glikokortikoîds H02AB02 94-0324 RpDiscus compositum, solution for injection Discus intervertebralis suis, Biologische Heilmittel Heel homeopâtisks lîdzeklis V03AX 01-0013 Rp

Acidum ascorbicum, Thiamini GmbH, Vâcijahydrochloridum, Natriiriboflavinum phosphoricum,Pyridoxini hydrochloridum, etc.

Drapolene cream, Cream Cetrimidum, Benzalkonium GlaxoSmithKline dermatoloìisks lîdzeklis D08AJ 01-0163 BezrecepðuChloridum Latvia SIA, Latvija

Encepur Children suspension for Vaccinum encephalitidis Chiron Behring GmbH & vakcîna pret çrèu J07BA01 01-0316 Rpinjection in pre-filled syringe 0, 25 ml, ixodibus advectae inactiv. Co KG, Vâcija encefalîtu (inaktivçta)Suspension for injection in pre-filledsyringe 0, 75 mcg/0, 25 mlEpirubicin �Ebewe� 2 mg/ml concentrate Epirubicini hydrochloridum Ebewe Pharma Ges.m.b.H onkoloìisks lîdzeklis L01DB03 02-0303 Rpfor, solution for infusion and solution Nfg.KG, Austrijafor injection for intravenous useExcipial fatty ointment, Fatty ointment Lipidum Spirig Baltikum Lithuanian - dermatoloìisks lîdzeklis D02AC 96-0092 Bezrecepðu

Swiss Ltd., Lietuva

Pârreìistrçtâs zâlesZâles tiek pârreìistrçtas ik pçc pieciem gadiem. Aicinâm vçrst uzmanîbu, ka pârreìistrâcijâ var tikt veiktas izmaiòasZâïu aprakstos un Lietoðanas instrukcijâs.

Page 13: Saturs Bßtiska informâcija

Fosamax 70 mg, tablets Acidum alendronicum SIA Merck Sharp & Dohme pretosteoporozes M05BA04 01-0131 RpLatvija, Latvija lîdzeklis

Garlic tablets Labofarm, Tablets 300 mg Bulbus Allii sativi Pharmaceutical Laboratory augu valsts preparâts V03AX 99-0796 Bezrecepðu�Labofarm�, Polija

Grippal sîrups pret saaukstçðanos ar Acidum ascorbicum, Echinaceae SIA �Natur Produkts�, Latvija pretsaaukstçðanâs lîdzeklis R05X 01-0052 Bezrecepðuehinâceju un C vitamînu, Sîrups herba extractum fluidum,

Eucalypti aetheroleum, Menthaepiperitae aetheroleum

Halixol 30 mg, tablets Ambroxoli hydrochloridum Egis Pharmaceuticals mukolîtisks lîdzeklis R05CB06 01-0046 BezrecepðuLtd., Ungârija

Imovax d.T. Adult, suspension for Vaccinum diphteriae et Aventis Pasteur S.A., Francija vakcîna pret difteriju un J07AM51 96-0188 Rpinjection in multidose vial tetani adsorbatum stingumkrampjiemImovax d.T. Adult, suspension Vaccinum diphteriae et Aventis Pasteur S.A., vakcîna pret difteriju un J07AM51 06-0098 Rpfor injection in prefilled syringe tetani adsorbatum Francija stingumkrampjiemIntralipid 30 %, emulsion for infusion Soiae oleum raffinatum Fresenius Kabi AB, Zviedrija parenterâlâs baroðanas B05BA02 01-0249 Rp

lîdzeklisIsoptin 2, 5 mg/ml, solution for injection Verapamili hydrochloridum Abbott GmbH & Co. KG, kalcija kanâlu blokators C08DA01 94-0122 Rp

Vertriebslinie Knoll, VâcijaKetocef 750 mg; 1,5 g powder for Cefuroximum SIA AWD Pharma, Latvija antibakteriâls lîdzeklis J01DC02 01-0151 Rpsolution for injection, Powder for 01-0152 Rpsolution for injection 750 mg; 1,5 gKliòìerîðu 20 % ziede ar E vitamînu Calendulae flos extractum SIA �Natur Produkts�, Latvija dermatoloìisks lîdzeklis D11AX 01-0051 Bezrecepðubiðu vaskâ, Ziede fluidum, Tocopheroli acetas,

Beta CarotinumLisinopril-Grindeks 10 mg; Lisinoprilum AS Grindeks, Latvija AKE inhibitors C09AA03 01-0222 Rp20 mg, tablets 01-0223 RpMucofalk orange granules, Granules 5 mg Testa Plantaginis ovatae Dr. Falk Pharma GmbH, Vâcija laksatîvs lîdzeklis A06A 01-0113 BezrecepðuNefrocarnit 1 g/3, 3 ml, oral solution L-Carnitinum Medice Arzneimittel Pütter metabolismu regulçjoðs A16AA01 00-1090 Rp

GmbH & Co.KG, Vâcija lîdzeklisNefrocarnit 1 g/5 ml, solution for injection L-Carnitinum Medice Arzneimittel Pütter metabolismu regulçjoðs A16AA01 00-1089 Rp

GmbH & Co.KG, Vâcija lîdzeklisNeuralgo-Rheum-Injeel solution for Causticum Hahnemanni, Biologische Heilmittel Heel homeopâtisks lîdzeklis V03AX 01-0110 Rpinjection, Solution for injection Colchicum autumnale, Citrullus GmbH, Vâcija

colocynthis, Ferrum metallicum,Lithium benzoicum, Gnaphaliumpolycephalum, Toxicodendronquercifolium, Filipendula ulmaria

Neurosal nomierinoðs sîrups ar Hyperici herba extractum SIA �Natur Produkts�, Latvija nomierinoðs lîdzeklis N05CM 01-0053 Bezrecepðuasinszâli un apiòiem, Sîrups fluidum, Humuli lupuli

extractum fluidumNimbex 2 mg/ml, solution for injection Cisatracurium GlaxoSmithKline Latvia miorelaksants M03AC11 01-0206 Rp

SIA, LatvijaNorflox 0, 3 % eye/ear drops, Norfloxacinum Cipla (UK) Limited, antibakteriâls lîdzeklis S03AA30 01-0175 RpEye/ear drops 0, 3 % LielbritânijaNovo-Passit film-coated tablets, Humulus lupulus, Crataegus Ivax Pharmaceuticals nomierinoðs lîdzeklis N05CM 00-0781 BezrecepðuFilm-coated tablets oxyacantha, Hypericum s.r.o., Èehija

perforatum, Melissa officinalis,Passiflora incarnata, Sambucusnigra, Valeriana officinalis,Guaifenasinum

Oliclinomel N 4-550E; 6-900E, Oleum Olivae raffinatum, Clintec Parenteral, Francija parenterâlâs baroðanas B05BA10 04-0068 Rpemulsion for infusion Oleum Sojae raffinatum, lîdzeklis 04-0069 Rp

Glycinum, Natrii acetas,Natrii glycerophosphas, Kaliichloridum, etc.

Orizolin 1000 mg, powder for injection Cefazolinum Zydus France SAS, Francija antibiotisks lîdzeklis J01DB04 94-0327 RpPenicillin Actavis G 1 000 000 IU, Benzylpenicillinum Actavis Nordic A/S, Dânija antibiotisks lîdzeklis J01CE01 00-1221 Rppowder for solution for injectionPentaglobin 50 mg/ml solution for Immunoglobulinum humanum Biotest Pharma GmbH, Vâcija cilvçka normâlais J06BA02 96-0187 Rpinfusion, Solution for i.v. infusion imûnglobulînsPikovit syrup, Syrup Retinolum, Cholecalciferolum, KRKA d.d., Novo Mesto, polivitamînu preparâts A11AA03 96-0111 Bezrecepðu

Acidum ascorbicum, SlovçnijaCyanocobalaminum, Nicotina-midum, Dexpanthenolum,Thiamini hydrochloridum, etc.

Sedalgin-Neo tablets, Tablets Paracetamolum, Metamizolum Actavis Nordic A/S, Dânija pretsâpju lîdzeklis N02BE51 00-1070 Rpnatricum, Coffeinum,Phenobarbitalum, Codeiniphosphas hemihydricus

Sîrups pret klepu bçrniem ar alteju Acidum ascorbicum, Althaeae SIA �Natur Produkts�, Latvija pretklepus lîdzeklis R05CA10 01-0101 Bezrecepðuun C vitamînu, Sîrups officinalis radix et folium

extr. fluidumSîrups pret klepu bçrniem ar alteju, Acidum ascorbicum, Althaeae SIA �Natur Produkts�, Latvija pretklepus lîdzeklis R05CA10 01-0100 Bezrecepðutimiânu un C vitamînu, Sîrups officinalis radix et folium extr.

fluidum, Thymi herbaextractum fluidum

Somatuline P.R. 30 mg, powder and Lanreotidum Beaufour Ipsen International, hormonu preparâts H01CB03 00-1008 Rpsolvent for suspension for prolonged Francijarelease injectionSpasmalgon solution for injection, Metamizolum natricum, SIA �Briz�, Latvija spazmolîtisks, A03DC 00-1068 RpSolution for injection Fenpiverini bromidum, analgçtisks lîdzeklis

Pitofenoni hydrochloridum

Zâïu valsts aìentûra Cito! � 3 (21) 13

Page 14: Saturs Bßtiska informâcija

14 Cito! � 3 (21) Zâïu valsts aìentûra

Species Digestantis, Species Cichorii radix, Millefolii herba, A/S �Rîgas farmaceitiskâ gremoðanu veicinoðs A16AX 01-0183 BezrecepðuRosae pseudo-fructus, Menthae fabrika�, Latvija lîdzeklispiperitae folium, Origani herba,Carvi fructus, Levistici radix

Stopangin solution, Oromucosal, Hexetidinum Ivax Pharmaceuticals antiseptisks lîdzeklis R02AA20 01-0099 Bezrecepðugargle solution s.r.o., ÈehijaStopangin spray, Oromucosal spray Hexetidinum Ivax Pharmaceuticals antiseptisks lîdzeklis R02AA20 01-0049 Bezrecepðu

s.r.o., ÈehijaStoptussin Fyto Syrup, Syrup Thymi extractum fluidum, Ivax Pharmaceuticals atkrçpoðanas lîdzeklis R05X 01-0010 Bezrecepðu

Serpylli extractum fluidum, s.r.o., ÈehijaPlantaginis extractum fluidum

Tramadol Krka 100 mg/2 ml, Tramadoli hydrochloridum KRKA d.d., Novo Mesto, narkotisks N02AX02 01-0148 Rpsolution for injection Slovçnija analgçtisks lîdzeklisTramadol Krka 50 mg/1 ml, Tramadoli hydrochloridum KRKA d.d., Novo Mesto, narkotisks N02AX02 96-0107 Rpsolution for injection Slovçnija analgçtisks lîdzeklisTrigan-D 10 mg/ml, solution for injection Dicyclomini hydrochloridum SIA �Unifarma�, Latvija spazmolîtisks lîdzeklis A03AA 01-0076 RpTrigan-D tablets, Tablets Paracetamolum, Dicyclomini SIA �Unifarma�, Latvija spazmolîtisks, pretsâpju N02BE51 01-0142 Bezrecepðu

hydrochloridum lîdzeklisUltravist-300; 370, solution for Iopromidum Schering AG, Vâcija rentgenkontrastlîdzeklis V08AB05 96-0119 Rpinjection and infusion 96-0120 RpXyzal 5 mg, coated tablets Levocetirizini dihydrochloridum UCB Pharma Oy, Somija prethistamîna lîdzeklis R06AE09 05-0407 RpZovirax 5 %, cream Aciclovirum GlaxoSmithKline Consumer pretvîrusu lîdzeklis D06BB03 96-0130 Bezrecepðu

Healthcare, GlaxoSmithKlineExport Ltd., Lielbritânija

Zovirax Ophthalmic Ointment, Aciclovirum GlaxoSmithKline Latvia pretvîrusu lîdzeklis S01AD03 96-0131 RpOphthalmic ointment 3 % SIA, LatvijaZoxon 1 mg; 2 mg; 4 mg, tablets Doxazosinum Zentiva a.s., Èehija antihipertensîvs lîdzeklis C02CA04 01-0095 Rp

01-0096 Rp01-0097 Rp

Izmaiòas Zâïu aprakstos un Lietoðanas instrukcijâsZâïu nosaukums Zâïu reìistrâcijas Reìistrâcijas Pamatojums

apliecîbas îpaðnieks Latvijas Zâïu reìistrâ numurs

Setronon injection PLIVA Krakow, 04-0156 Papildinâta sadaïa �Brîdinâjumi�4 mg/2 ml; 8 mg/4 ml Pharmaceutical Company, 04-0157

PolijaSubutex 0,4 mg; 2 mg; 8 mg Schering-Plough Europe, 05-0400 II tipa izmaiòas � papildinâtas sadaïas �Devas un lietoðanas veids�,

Sublingual tablets Beïìija 05-0401 �Îpaði brîdinâjumi un piesardzîba lietoðanâ�, �Mijiedarbîba ar citâm05-0402 zâlçm un citi mijiedarbîbas veidi�

Nexium 20 mg;40 mg AstraZeneca AB, 02-0076 Papildinâtas sadaïas �Devas�, �Blakusparâdîbas�gastro-resistant tablets Zviedrija 02-0077

Zinnat 125 mg;250 mg; GlaxoSmithKline Latvia 97-0233 Papildinâta sadaïa �Blakusparâdîbas�500 mg; 125 mg/5 ml SIA, Latvija 97-0234coated tablets, granuel suspension making 97-0235

97-0049Cipralex 5 mg; 10 mg; H.Lundbeck A/S, Dânija 02-0209 Papildinâta indikâcija �Ìeneralizçtas trauksmes ârstçðana�

15 mg;20 mg; coated tablets 02-021002-021102-0212

Madopar HBS 125 Roche Latvija SIA, Latvija 96-0353 Papildinâtas indikâcijas �Nemierîgo kâju sindroms� un sadaïascapsules �Devas�, �Brîdinâjumi�

Madopar 100/25 Roche Latvija SIA, Latvija 00-0724 Papildinâtas indikâcijas �Nemierîgo kâju sindroms� un sadaïascapsules;200/50 tablets; 96-0643 �Devas�, �Brîdinâjumi�100/25 dispersible tablets 00-0723

Seroxat 10 mg;20 mg; 30 mg Glaxo Group Limited, 04-0114 II tipa izmaiòas ZA un LI sadaïâ �Grûtniecîba un zîdîðana�Lielbritânija 99-1041

Paroxat 10 mg;20 mg; 30 mg 04-0115film-coated tablets 04-0111

04-011304-0112

Pulmicort Turbuhaler AstraZeneca AB, Zviedrija 97-0645 Atjaunota indikâcija �Hroniskas obstruktîvas plauðu slimîbas100 micgromas/actuation inhalation powder 97-0646 ârstçðanai (HOPS).Izvçrtçt terapiju ne âtrâk kâ pçc 3-6 mçn.�

Oxis Turbuhaler AstraZeneca AB, Zviedrija 98-0533 Papildinâtas sadaïas �Devas�, �Brîdinâjumi�4,5 micrograms/dose; 9 micrograms/dose 98-0532inhalation powder

Magrilan 20 mg Medochemie Ltd, Kipra 03-0163 Papildinâta sadaïa �Brîdinâjumi�tablets

Glucophade XR 500 mg Merck Sante, Francija 04-0289 Papildinâtas sadaïas �Kontrindikâcijas�, �Blakusparâdîbas�extended release tabletsWellbutrin SR GlaxoSmithKline Latvia 99-1047 Pievienota norâde � bçrniem un pusaudþiem lîdz 18 gadu vecumam

SIA, Latvija Nelieto. Papildinâta sadaïa �Blakusparâdîbas�UFT hard capsules Bristol-Myers Squibb 98-0861 Papildinâta sadaïa �Mijiedarbîba�

AS, IgaunijaArketis 20 mg Meochemie Ltd, Kipra 04-0080 Papildinâta sadaïa �Brîdinâjumi�

tablets

Page 15: Saturs Bßtiska informâcija

Caduet 5 mg/10 mg; 10 mg/10 mg Pfizer Europe MA EEIG, 06-0020 IA tipa izmaiòasfilm-coated tablets Lielbritânija 06-0021

Zocor 10 mg;20 mg Merck Sharp&Dohme Latvija, 98-0813 Papildinâta sadaïa �Mijiedarbîba�coated tablets Latvija 98-0814

Rispen 1 mg;2 mg; Zentiva A.S. Èehija 05-0178 ZA un LI papildinâta ar droðîbas informâciju3 mg; 4 mg film-coated tablets 05-0179

05-018005-0181

Losec 40 mg powder Astra Zeneca, Zviedrija 98-0306 II tipa izmaiòas. ZA un LI veikti papildinâjumi sadaïâs �Mijiedarbîba ar citâm zâlçmfor solution for injection un citi mijiedarbîbas veidi�, �Grûtniecîba un zîdîðana�, �Nevçlamâs blakusparâdîbas�

Flixonase � Glaxo Wellocome Operations 02-0266 ZA un LI papildinâta ar droðîbas informâcijuNasule drops Ltd., Lielbritânija

Triquilar coated tablets Schering AG, Vâcija 94-0171 ZA un LI papildinâta ar droðîbas informâciju

Avodart 0,5 mg Glaxo Group Limited, 04-0410 II tipa izmaiòas ZA un LI veikti papildinâjumi sadaïâs �Blakusparâdîbas�,soft capsule Lielbritânija �Grûtniecîba un zîdîðana�

Gracial N.V. Organon, Nîderlande 98-0545 Papildinâta sadaïa �Brîdinâjumi�tablets

Celebrex 100 mg; Pfizer Limited, Anglija 01-0288 ZA un LI papildinâta ar droðîbas instrukciju200 mg capsule hard 01-0289

Procto-Glyvenol Novartis Finland Oy, 98-0567 Papildinâtas sadaïas �Nevçlamâs blakusparâdîbas�,rectal cream Somija �Iespçjamâs blakusparâdîbas�

Procto-Glyvenol Novartis Finland Oy, 98-0566 Papildinâtas sadaïas �Nevçlamâs blakusparâdîbas�,suppository Somija �Iespçjamâs blakusparâdîbas�

Jeanine 30/2000 Jenapharm GmbH&Co.KG, 02-0097 Papildinâta sadaïa �Brîdinâjumi�micrograms coated tablets Vâcija

Logest 0,075 mg;0,02 mg Schering AG, Vâcija 98-0525 Papildinâta sadaïa �Brîdinâjumi�coated tablets

Microgynon 30 Schering AG, Vâcija 96-0296 Papildinâta sadaïa �Brîdinâjumi�coated tablets

Femoden 75/35 Schering AG, Vâcija 97-0161 Papildinâta sadaïa �Brîdinâjumi�micrograms coated tablets

Mirelle 60/15 micrograms Schering AG, Vâcija 02-0068 Papildinâta sadaïa �Brîdinâjumi�coated tablets

Diane-35 Schering AG, Vâcija 94-0169 Papildinâta sadaïa �Brîdinâjumi�coated tablets

Gemzar 200 mg; 1 g Eli Lilly Holdings limited, 00-0393 Papildinâtas sadaïas �Brîdinâjumi�, �Mijiedarbîba�powder for solution for infusion Lielbritânija 00-0394

Wellbutrin SR GlaxoSmithKline Latvia SIA, 99-1047 Papildinâtas sadaïas �Brîdinâjumi�, Blakusparâdîbas�, �Mijiedarbîba�extended release coated tablets Latvija

Neupogen 300 micrograms AMGEN EUROPE B.V. 05-0566 Papildinâtas sadaïas �Brîdinâjumi�, �Blakusparâdîbas�(0,6 mg/ml);480 micrograms (0,96 mg/ml) Nîderlande 05-0567solution for injection in pre-filled syringe

Diovan 40 mg;80 mg;160 mg;320 mg Novartis Finland Oy., 02-0390 Papildinâta sadaïa �Mijiedarbîba�coated tablets Somija 02-0391

02-039206-0050

Cardura 1 mg;2 mg;4 mg Pfizer Limited, Anglija 96-0658 Papildinâtas sadaïas �Îpaði brîdinâjumi un piesardzîbatablets 02-0172 lietoðanâ�, �Mijiedarbîba ar citâm zâlçm un citi mijiedarbîbas

02-0173 veidi� un droðîbas informâcijaStatex 10 mg; 20 mg SIA AWD Pharma, 03-0460 Papildinâta droðîbas informâcija

coated tablets Latvija 03-0461Leukeran 2 mg SIA GlaxoSmithKline Latvia, 99-0875 Papildinâtas sadaïas �Îpaði brîdinâjumi un piesardzîba

coated tablets Latvija lietoðanâ�, �Nevçlamâs blakusparâdîbas�Androcur 50 mg Schering AG, Vâcija 95-0266 Papildinâtas sadaïas �Îpaði brîdinâjumi un piesardzîba

tabletes lietoðanâ�, Mijiedarbîba ar citâm zâlçm un citi mijiedarbîbas veidi�, �Nevçlamâsblakusparâdîbas un droðîbas informâcija

Dermovate GlaxoSmithKline Latvia SIA, 97-0465 Papildinâta droðîbas informâcija, �Brîdinâjumi�, �Blakusparâdîbas�Latvija

Stieprox 1,5 % shampoo Stiefel Laboratories Ltd, 05-0397 Papildinâta sadaïa �Îpaði brîdinâjumi un piesardzîbaAnglija lietoðanâ�

Zaditen 1 mg tablets Novartis Finland OY,Somija 93-0440 Papildinâta sadaïa �Nevçlamâs blakusparâdibas�Patentex oval N Merz Pharmaceuticals GmbH, 04-0015 Papildinâtas sadaïas �Nevçlamâs blakusparâdîbas�

75 mg pessaries Vâcija �Iespçjamâs blakusprâdîbas�Fludara oral Schering AG,Vâcija 03-0260 Papildinâta sadaïas �Indikâcijas�, �Blakusparâdîbas�

coated tabletsFortzar SIA �Merck Sharp&Dohme 04-0232 Papildinâtas sadaïas �Îpaði brîdinâjumi un piesardzîba

coated tablets Latvija�, Latvija lietoðanâ�, �Mijiedarbîba ar citâm zâlçm un citi mijiedar-bîbas veidi�, �Nevçlamâs blakusparâdîbas�

Activelle 1 mg/05 mg Novo Nordisk A/S Dânija 05-0410 Papildinâta sadaïa �Brîdinâjumi�film-coated tablet

Hedelix s.a. Krewel Meuselbach GmbH 98-0335 Papildinâta sadaïa �Îpaði brîdinâjumi un piesardzîba lietoðanâ�drops

Yarina Schering AG, Vâcija 00-0463 Papildinâta droðîbas informâcijacoated tablets

Monozide 20 mg/12,5 mg Bristol-Myers Squibb 03-0033 Papildinâta sadaïa �Brîdinâjumi�tablets Eesti AS, Igaunija

Zâïu valsts aìentûra Cito! � 3 (21) 15

Page 16: Saturs Bßtiska informâcija

16 Cito! � 3 (21) Zâïu valsts aìentûra

Ârstniecîbas lîdzekïa nosaukums, zâïu Starptautiskais nosaukums Zâïu reìistrâcijas Farmakotera- ATÍ kods Reìistrâ- Izplatîðanaforma un dozçjums apliecîbas îpaðnieks peitiskâ grupa cijas Nr.

Abufene, Tablets 400 mg Beta alaninum Bouchara-Recordati, Francija ginekoloìisks lîdzeklis G02C 98-0336 BezrecepðuAcetylsalicylic acid, Tablets 325 mg Acidum acetylsalicylicum PHARMA SCIENCE, Kanâda nesteroidâls pretiekaisuma N02BA01 00-0272 Bezrecepðu

lîdzeklisAcidum acetylsalicylicum, Acidum acetylsalicylicum Borisov Medical Preparation nesteroidâls pretiekaisuma N02BA01 00-0757 BezrecepðuTabulettae 0,5 g Plant, Baltkrievija lîdzeklisAcidum acetylsalicylicum, Acidum acetylsalicylicum Tallinas Farmaceitiskâ nesteroidâls pretiekaisuma N02BA01 98-0381 BezrecepðuTablets 500 mg fabrika AS, Igaunija lîdzeklisAcidum acetylsalicylicum, Acidum acetylsalicylicum Moschimpharmpreparaty, pretsâpju, pretdrudþa N02BA01 00-0058 BezrecepðuTablets 500 mg v.n. N.A.Semaðko, Krievija lîdzeklisAcidum aminocapronicum, Acidum aminocapronicum JSC �Belmedpreparat�, antifibrinolîtisks lîdzeklis B02AA01 00-0424 RpSolutio pro injectionibus 5 % BaltkrievijaAcidum aminocapronicum, Solutio Acidum aminocapronicum, Moschimpharmpreparaty, antifibrinolîtisks lîdzeklis B02AA01 00-0079 Rppro injectionibus 5 % Natrii chloridum v.n. N.A.Semaðko, KrievijaAcidum ascorbinicum 0,05 g, Dragee Acidum ascorbicum A/S Kijevas vitamînu vitamînu preparâts A11GA01 00-0311 Bezrecepðu

rûpnîca, UkrainaAcidum ascorbinicum 5 %, Acidum ascorbicum Borisov Medical Preparation vitamînu preparâts A11GA01 00-1212 RpSolutio pro injectionibus 5 % Plant, BaltkrievijaAcidum ascorbinicum cum glucoso, Acidum ascorbicum, Glucosum Kievskiy vitaminiy zavod, vitamînu preparâts A11GA 00-0880 BezrecepðuTabulettae 0,1 g JSC, UkrainaAcidum boricum, Pulvis Acidum boricum Moschimpharmpreparaty, antiseptisks lîdzeklis S02AA03 00-0629 Bezrecepðu

v.n. N.A.Semaðko, KrievijaAcidum nicotinicum, Tabulettae Acidum nicotinicum Vitamîni, Umaòas R/A, vitamînu preparâts A11HA 00-0198 Bezrecepðu

UkrainaAevit in capsules, Capsulae Retinoli palmitas, JSC �Minskintercaps�, vitamînu preparâts A11JA 00-0882 Rp(A vit.100 000 IU; E vit. 100 mg) Tocopheroli acetas BaltkrievijaAHD 2000, Losung Ethanolum Lysoform Desinfection dezinfekcijas lîdzeklis D08AX08 94-0176 Bezrecepðu

AG, ÐveiceAllocholum, Tabulettae obductae Chole medicatum, Folia JSC �Belmedpreparat�, þultsdzinçjs lîdzeklis A05AX 99-0995 Bezrecepðu

Urticae, Allium sativum BaltkrievijaAlumag suspension, Suspension Magnesii hydroxidum, Grodzinsk Pharmaceutical antacîds lîdzeklis A02AA10 96-0416 Bezrecepðu

Aluminii hydroxydum Works �Polfa�, PolijaAminalonum, Acidum aminobutyricum Vitamîni, Umaòas R/A, nootrops lîdzeklis N03AG03 00-0531 BezrecepðuTabulettae obductae 250 mg UkrainaAmixinum 125 mg, Tabulettae Tiloronum SIA �LENS-Farm�, Krievija imûnmodulators L03A 00-0307 RpAmosept, Losung Didecyl-dimethylammonii Lysoform Desinfection dezinfekcijas lîdzeklis D08AJ06 94-0208 Rp

chloridum AG, ÐveiceAmpicillin 500 mg I.M./I.V., Powder Ampicillinum Balkanpharma-Razgrad antibiotisks lîdzeklis J01CA01 97-0074 Rpfor solution for injection AD, BulgârijaAmpicillini trihidras, Tabulettae 0,25 g Ampicillinum trihydricum Borisov Medical Preparation antibiotisks lîdzeklis J01CA01 00-0883 Rp

Plant, BaltkrievijaAmpicillini trihydras, Capsulae 250 mg Ampicillinum trihydricum Borisov Medical Preparation antibiotisks lîdzeklis J01CA01 00-0427 Rp

Plant, BaltkrievijaAmpicillini trihydras, Tabulettae Ampicillinum trihydricum JSC �Belmedpreparat�, antibiotisks lîdzeklis J01CA01 00-0062 Rp

BaltkrievijaAmpicillinum,Oxacillinum-Borimed, Ampicillinum trihydricum, Borisov Medical Preparation antibiotisks lîdzeklis J01CA51 00-0758 RpCapsulae 0,25 g Oxacillinum natricum Plant, BaltkrievijaAmpicillinum-natrium, Pulvis pro Ampicillinum natricum Borisov Medical Preparation antibiotisks lîdzeklis J01CA01 00-1150 Rpinjectionibus 0,5 g Plant, BaltkrievijaAmpicillinum-Oxacillinum, Ampicillinum trihydricum, JSC �Belmedpreparat�, antibiotisks lîdzeklis J01CA51 00-0061 RpCapsulae 0,25 g Oxacillinum natricum BaltkrievijaAnalginum 50 %, solutio pro Metamizolum natricum A/S �Kalceks�, Latvija pretsâpju, pretdrudþa N02BB02 99-0544 Rpinjectionibus, Solutio pro lîdzeklisinjectionibus 50 %Analginum, Solutio pro Metamizolum natricum Borisov Medical Preparation pretsâpju lîdzeklis N02BB02 00-1147 Rpinjectionibus 25 %; 50 % Plant, Baltkrievija 00-1148 RpAnalginum, Tabulettae 0,5 g Metamizolum natricum JSC �Belmedpreparat�, pretsâpju lîdzeklis N02BB02 00-1213 Rp

BaltkrievijaAnalginum, Tabulettae 0,5 g Metamizolum natricum Tathimfarmpreparati, Krievija pretsâpju lîdzeklis N02BB02 00-1044 RpAndriol, Capsules 40 mg Testosteroni undecanoas N.V. Organon, Nîderlande hormonu preparâts G03BA03 98-0073 RpAntiFlu, Effervescent granulate Paracetamolum, Sagmel, Inc., ASV pretsaaukstçðanâs lîdzeklis N02BE51 99-1010 Bezrecepðu

Pseudoephedrinum,Chlorpheniraminum

Antigrippocaps, Capsulae Acidum acetylsalicylicum, JSC �Minskintercaps�, pretsaaukstçðanâs lîdzeklis N02BA51 00-0074 BezrecepðuAcidum ascorbicum, etc. Baltkrievija

Artiso Nhan Tran Tea, Tea (filtered bag) Folium Cynarae, Flos Cynarae, Oriental Pharmaceutical vispârtonizçjoðs lîdzeklis V03AX 00-0840 BezrecepðuRadix Cynarae,etc. Corporation 5 - FIDOPHARM,

VjetnamaAsaphen 80, Chewable tablets 80 mg Acidum acetylsalicylicum PHARMA SCIENCE, Kanâda nesteroidâls pretiekaisuma N02BA01 00-0150 Bezrecepðu

lîdzeklisAscophenum- P, Tabulettae Paracetamolum, Acidum JSC �Belmedpreparat�, pretsâpju lîdzeklis N02BE51 99-0998 Bezrecepðu

acetylsalicylicum, Coffeinum BaltkrievijaAscorutinum, Tabulettae Acidum ascorbicum, Rutinum JSC �Belmedpreparat�, vitamînu preparâts A11JC 00-0321 Bezrecepðu

Baltkrievija

No Zâïu reìistra izslçgtâs zâlesIzslçgtas no LR Zâïu reìistra daþâdu iemeslu dçï (beidzies reìistrâcijas apliecîbas derîguma termiòð,atsauktas no LR Zâïu reìistra pçc raþotâjsabiedrîbas iniciatîvas, zâles reìistrçtas centralizçti)

Page 17: Saturs Bßtiska informâcija

Asparcam Tablets, Tablets Magnesii asparaginas, LE �Lugansk Chemical- kâlija un magnija preparâts A12BA30 99-0805 RpKalii asparaginas Pharmaceutical Plant�, Ukraina

Aspir Low, Enteric-coated tablets 81 mg Acidum acetylsalicylicum Major Pharmaceuticals, antitrombotisks lîdzeklis B01AC06 94-0205 BezrecepðuInc., ASV

Bactiflox-250 Lactab, Lactab (film- Ciprofloxacinum Mepha Lda., Portugâle antibakteriâls lîdzeklis J01MA02 99-0303 Rpcoated tablets) 250 mgBalsamum Hippopheae, Extr.Hippopheae rhamnoidis L. SIA �ÐAAR�, Latvija tautas dziedniecîbas lîdzeklis D03AX 93-0525 BezrecepðuExtractum oleosumBefunginum, Liquor Extr. Fungi betulini Tathimfarmpreparati, Krievija tonizçjoðs un pretsâpju A13A 99-0917 Bezrecepðu

lîdzeklisBellasthesinum, Tabulettae Extr. Belladonnae, Tathimfarmpreparati, Krievija spazmolîtisks, A03DB 99-0806 Bezrecepðu

Anaesthesinum pretsâpju lîdzeklisBenzylpenicillinum-KMP, Pulvis Benzylpenicillinum natricum A/S Kijevmedpreparat, antibiotisks lîdzeklis J01CE01 00-1151 Rppro injectionibus 1 000 000 U UkrainaBenzylpenicillinum-KMP, Pulvis Benzylpenicillinum natricum A/S Kijevmedpreparat, antibiotisks lîdzeklis J01CE01 00-1055 Rppro injectionibus 500 000 U UkrainaBenzylpenicillinum-natrium 1 000 000 U, Benzylpenicillinum Kraspharma, JSC, Krievija antibiotisks lîdzeklis J01CE01 00-1038 RpPulvis pro injectionibus 1 000 000 UBetadine surgical scrub, Povidonum iodinatum Egis Pharmaceuticals antiseptisks lîdzeklis D08AG02 01-0155 BezrecepðuSolution 75 mg/ 1 ml Ltd., UngârijaBilax, Coated tablets 5 mg Bisacodylum Jaka 80 AD, Maíedonija caurejas lîdzeklis A06AB02 00-1122 RpBismuth Liquid, Suspension Bismuthi subsalicylas Sagmel, Inc., ASV gastroenteroloìisks lîdzeklis A07BB 00-0268 BezrecepðuBismuth Tablets, Chewable tablets 262 mg Bismuthi subsalicylas Sagmel, Inc., ASV gastroenteroloìisks lîdzeklis A07BB 00-0267 BezrecepðuBubil, Shampoo Pyrethrinum Jaka 80 AD, Maíedonija pretpedikulozes lîdzeklis P03AC01 00-1017 RpButadionum, Tabulettae 0,15 g Phenylbutazonum Moschimpharmpreparaty, nesteroidâls pretiekaisuma M01AA01 00-0080 Rp

v.n. N.A.Semaðko, Krievija lîdzeklisButadionum, Tabulettae 0,15 g Phenylbutazonum Galychpharm, JSC, Ukraina nesteroidâls pretiekaisuma M01AA01 00-1051 Rp

lîdzeklisCalcii chloridum 10 %, Calcii chloridum A/S �Kalceks�, Latvija kalcija preparâts A12AA07 95-0127 RpSolutio pro injectionibus 10 %Calcii gluconas 10 %, Calcii gluconas A/S �Kalceks�, Latvija kalcija preparâts A12AA03 00-0970 RpSolutio pro injectionibus 10 %Candid cream, Cream 1 % Clotrimazolum M/s Glenmark pretsçnîðu lîdzeklis D01AC01 00-0953 Rp

Pharmaceuticals Ltd, IndijaCandid lotion, Lotion 1 % Clotrimazolum M/s Glenmark pretsçnîðu lîdzeklis D01AC01 00-0850 Rp

Pharmaceuticals Ltd, IndijaCandid-B cream, Cream Beclometasonum, M/s Glenmark pretsçnîðu lîdzeklis D07X 00-0849 Rp

Clotrimazolum Pharmaceuticals Ltd, IndijaCaptoprilum-KMP, Tabulettae 25 mg Captoprilum A/S Kijevmedpreparat, AKE inhibitors, C09AA01 00-0638 Rp

Ukraina antihipertensîvs lîdzeklisCarbenicillinum-dinatricum 1,0 g, Carbenicillinum-dinatricum AS �Brincalov A�, antibiotisks lîdzeklis J01CA03 94-0320 RpPulvis pro injectionibus 1,0 gCefazolinum-KMP, Cefazolinum natricum A/S Kijevmedpreparat, Ukraina antibiotisks lîdzeklis J01DA04 00-0881 RpPulvis pro injectionibus 1 gCelanidum-KMP, Tablets 0,00025 g Lanatosidum C A/S Kijevmedpreparat, Ukraina sirds glikozîds C01AA06 00-0084 RpCetirizine Mepha-10 mg, Tablets Cetirizini hydrochloridum Mepha Lda., Portugâle prethistamîna lîdzeklis R06AE07 04-0225 BezrecepðuC-Film Lucchini, Vaginal film 72 mg Nonoxynolum Laboratoire Lucchini pretapaugïoðanâs lîdzeklis G02BB 00-0727 Bezrecepðu

S.A., ÐveiceCharlieu Anti-Lice , shampoo Permethrinum Laboratoires Mayoly pretpedikulozes lîdzeklis P03AC04 00-0486 Bezrecepðu

Spindler, FrancijaCharlieu Topicrem, Emulsion Ureum, Glycerinum Laboratoires Mayoly dermatoloìisks lîdzeklis D11AX 00-0832 Bezrecepðu

Spindler, FrancijaCifran Infusion, Infusion 2 mg/ ml Ciprofloxacinum Ranbaxy Laboratories antibakteriâls lîdzeklis J01MA02 96-0247 Rp

Limited, IndijaCipramil 40 mg, Coated tablets Citalopramum H. Lundbeck A/S, Dânija antidepresants N06AB04 01-0422 RpCitramon-Borimed, Tabulettae Acidum acetylsalicylicum, Borisov Medical Preparation pretsâpju lîdzeklis N02BE51 00-1056 Bezrecepðu

Paracetamolum, Coffeinum Plant, BaltkrievijaCitramonum P, Tabulettae Paracetamolum, Acidum JSC �Belmedpreparat�, pretsâpju lîdzeklis N02BE51 99-0996 Bezrecepðu

acetylsalicylicum, Coffeinum BaltkrievijaCitramonum P, Tabulettae Acidum acetylsalicylicum, Moschimpharmpreparaty, pretsâpju lîdzeklis N02BA51 00-0057 Bezrecepðu

Paracetamolum, Coffeinum v.n. N.A.Semaðko, KrievijaCitramonum P, Tabulettae Acidum acetylsalicylicum, Tathimfarmpreparati, Krievija pretsâpju lîdzeklis N02BE51 00-1043 Bezrecepðu

Paracetamolum, CoffeinumCitrapacum, Tabulettae Acidum acetylsalicylicum, A/S �Ufavita�, Krievija pretsâpju, pretdrudþa N02BA51 00-1207 Bezrecepðu

Paracetamolum, etc. lîdzeklisClob cream, Cream 1 % Clotrimazolum Indoco Remedies Ltd, Indija pretsçnîðu lîdzeklis D01AC01 00-1020 BezrecepðuClophelinum, Tabulettae 0,15 mg Clonidini hydrochloridum Moschimpharmpreparaty, antihipertensîvs lîdzeklis C02AC01 00-0752 Rp

KrievijaColdact Plus, Syrup Phenylpropanolaminum, Natco Pharma Ltd, Indija pretsaaukstçðanâs lîdzeklis R01BA51 95-0221 Rp

ChlorphenaminumColpotrophine, Vaginal cream 1 % Promestrienum Laboratoire Theramex, estrogçns lîdzeklis G03CA09 01-0140 Rp

MonakoComsi, Spray Benzocainum, Mentholum, SIA �Leopolds�& pretapdeguma, medicîniskâs D11A 93-0437 Bezrecepðu

Extr. Propolisi fluidum �Aerosols�, Latvija kosmçtikas lîdzeklisCordaflex 10 mg;20 mg, Nifedipinum Egis Pharmaceuticals kalcija kanâlu blokators C08CA05 01-0087 RpFilm-coated tablets Ltd., Ungârija 01-0088 RpCorn Plast, Emplastrum adhaesivum Acidum salicylicum Medi Surgichem Pvt. dermatoloìisks lîdzeklis D11AF 00-0851 Bezrecepðu

Ltd., IndijaCortex Quercus, Species Cortex Quercus SIA �Planta Medica Ltd.�, savelkoðs lîdzeklis V03AX 00-0414 Bezrecepðu

LatvijaCutasept FP, Solution Propanolum, BODE Chemie GmbH & dezinfekcijas lîdzeklis D08AJ 00-0693 Rp

Benzalkonii chloridum Co., VâcijaCystone, Tablets Extr. Didymocarpi pedicellatae, The Himalaya Drug Co., Indija ajurvedas lîdzeklis V03AX 01-0077 Bezrecepðu

Extr. Saxifragae ligulatae, etc. (alternatîvâs medicînaslîdzeklis)

Zâïu valsts aìentûra Cito! � 3 (21) 17

Page 18: Saturs Bßtiska informâcija

18 Cito! � 3 (21) Zâïu valsts aìentûra

Diazolinum, Dragee 0,1g Mebhydrolinum Farmak, JSC, Ukraina prethistamîna lîdzeklis R06AX 99-0746 RpDibazolum, Solutio pro Bendazolum Borisov Medical Preparation perifçriskos asinsvadus C04AB 00-0428 Rpinjectionibus 0,5 % Plant, Baltkrievija paplaðinoðs lîdzeklisDiclofenac, Solutio pro Diclofenacum natricum Moschimpharmpreparaty, nesteroidâls M01AB05 00-0750 Rpinjectionibus 2,5 % Krievija pretiekaisuma lîdzeklisDiclofenacum natricum 2,5 %, Diclofenacum natricum A/S �Kalceks�, Latvija nesteroidâls pretiekaisuma M01AB05 94-0092 RpSolutio pro injectionibus 2,5 % lîdzeklisDiclomol EC 50, Enteric- Diclofenacum natricum Win-Medicare Limited, Indija nesteroidâls pretiekaisuma M01AB05 98-0127 Rpcoated tablets 50 mg lîdzeklisDiclomol Gel, Gel 1 % Diclofenacum natricum Win-Medicare Limited, Indija nesteroidâls pretiekaisuma M02AA15 98-0129 Bezrecepðu

lîdzeklisDiclomol SR Tabs, Sustained- Diclofenacum natricum Win-Medicare Limited, Indija nesteroidâls pretiekaisuma M01AB05 98-0128 Rprelease tablets 100 mg lîdzeklisDiclomol, Solution for Diclofenacum natricum Win-Medicare Limited, Indija nnesteroidâls pretiekaisuma M01AB05 98-0126 Rpinjection 75 mg/ 3 ml lîdzeklisDicloran, Solution for injection Diclofenacum natricum Unique Pharmaceutical nesteroidâls pretiekaisuma M01AB05 01-0141 Rp75 mg/ 3 ml Laboratories, Indija lîdzeklisDigoxinum, Solutio pro Digoxinum Moschimpharmpreparaty, sirds glikozîds C01AA05 00-0306 Rpinjectionibus 0,025 % v.n. N.A.Semaðko, KrievijaDimedrolum 1 %, Solutio Diphenhydramini Kalceks, PVU, Latvija prethistamîna lîdzeklis R06AA02 99-0166 Rppro injectionibus 1 % hydrochloridumDimedrolum, Solutio Diphenhydraminum Moschimpharmpreparaty, prethistamîna lîdzeklis R06AA02 00-1205 Rppro injectionibus 1 % KrievijaDimedrolum, Tablets 0,05 g Diphenhydramini A/S �Galièfarm�, Ukraina prethistamîna lîdzeklis R06AA02 99-0492 Rp

hydrochloridumDimedrolum, Tabulettae 0,05 g Diphenhydramini JSC �Belmedpreparat�, prethistamîna lîdzeklis R06AA02 00-0423 Rp

hydrochloridum BaltkrievijaDimedrolum, Tabulettae 0,05 g Diphenhydraminum Moschimpharmpreparaty, prethistamîna lîdzeklis R06AA02 00-1048 Rp

KrievijaDimexidum, Liquid Dimethyl ether Galychpharm, JSC, Ukraina pretsâpju, pretiekaisuma M02AX03 00-0310 Rp

lîdzeklisDimexidum, Solution for external use Dimethylis sulfoxidum Tathimfarmpreparati, pretsâpju, pretiekaisuma M02AX03 99-0497 Rp

Kazaòas ÍFRA, Krievija lîdzeklisDoxycyclini hydrochloridum, Doxycyclini hydrochloridum JSC �Belmedpreparat�, antibiotisks lîdzeklis J01AA02 00-0320 RpCapsulae 0,1 g BaltkrievijaDoxycyclini hydrochloridum, Doxycyclini hydrochloridum Borisov Medical Preparation antibiotisks lîdzeklis J01AA02 00-0756 RpCapsulae 0,1 g Plant, BaltkrievijaDriminate, Tablets 50 mg Dimenhydrinatum Major Pharmaceuticals, pretvemðanas lîdzeklis N07CA 95-0039 Bezrecepðu

Inc., ASVDryphen, Coated tablets Paracetamolum, Phenylephrini Major Pharmaceuticals, pretsaaukstçðanâs lîdzeklis N02BE51 95-0040 Bezrecepðu

hydrochloridum, Inc., ASVChlorphenamini maleas

Dusopharm, Tabulettae obductae 50 mg Naftidrofurylum Unipharm, Bulgârija perifçriskos asinsvadus C04AX21 99-1007 Bezrecepðupaplaðinoðs lîdzeklis

Ecalin, Cream 1 % Econazoli nitras Jaka 80 AD, Maíedonija pretsçnîðu lîdzeklis D01AC03 00-1015 RpEcalin, Spray 1 % Econazoli nitras Jaka 80 AD, Maíedonija pretsçnîðu lîdzeklis D01AC03 00-1014 RpEcalin, Vaginal pessaries 150 mg Econazoli nitras Jaka 80 AD, Maíedonija pretsçnîðu lîdzeklis G01AF05 00-1016 RpEglonyl, Tablets 200 mg Sulpiridum Sanofi-Synthelabo France, neiroleptisks lîdzeklis N05AL01 01-0129 Rp

FrancijaEglonyl, Capsulae 50 mg Sulpiridum Sanofi-Synthelabo France, neiroleptisks lîdzeklis N05AL01 01-0128 Rp

FrancijaEglonyl, Solution for i.m. Sulpiridum Sanofi-Synthelabo France, neiroleptisks lîdzeklis N05AL01 01-0127 Rpinjection 100 mg/ 2 ml FrancijaEhrlich Balsam Joint + Oleum Eucalypti, Camphora, Allgauer Heilmoor Ehrlich vietçji kairinoðs lîdzeklis, M02AX10 00-0679 BezrecepðuMuscle Balsam , Ointment Mentholum, etc. GmbH & Co. KG, Vâcija antireimatisks lîdzeklisElixir �Altaysky�, Liquid Fructus Pini sibirica, Folia Vitis A/S �Meligen�, Krievija tautas dziedniecîbas lîdzeklis V03AX 00-0634 Bezrecepðu

idaeae, etc.Elixir �Demidovsky�, Liquid Herba Millefolii, Herba Origani A/S �Meligen�, Krievija tautas dziedniecîbas lîdzeklis V03AX 00-0635 Bezrecepðu

vulgaris, etc.Elixir �Kedrovit�, Liquid Fructus Pini sibirica, Fructus A/S �Meligen�, Krievija vispârspçcinoðs lîdzeklis V03AX 00-0747 Bezrecepðu

Aroniae melanocarpae, etc.Elixir �Kliophyt�, Liquid Fructus Anisi pimpinellae, A/S �Meligen�, Krievija vispârspçcinoðs sedatîvs V03AX 00-0748 Bezrecepðu

Fructus Crataegi, etc. lîdzeklisEnalaprilum-Mepha 5 mg; 20 mg, Tablets Enalaprili maleas Mepha Lda., Portugâle AKE inhibitors, C09AA02 03-0194 Rp

antihipertensîvs lîdzeklis 03-0196 RpEphedrini hydrochloridum 5 %, Ephedrini hydrochloridum MASKAVAS ENDOKRÎNÂ adrenomimçtisks lîdzeklis R03CA02 00-0755 RpSolutio pro injectionibus 5 % RÛPNÎCA, KrievijaErynitum, Tabulettae 0,01 g Pentaerithrityli tetranitras Tathimfarmpreparati, Krievija antianginâls lîdzeklis C01DA05 00-0975 RpErythromycini phosphas 0,1 g, Erythromycini phosphas KAS �Sintez�, Krievija antibakteriâls lîdzeklis J01FA01 00-1208 RpPulvis pro injectionibus 0,1 gErythromycinum, Tablets 0,25 g Erythromycinum Moschimpharmpreparaty, antibiotisks lîdzeklis J01FA01 99-0833 Rp

v.n. N.A.Semaðko, KrievijaEsmeron 250 mg = 25 ml, Solution for Recuronii bromidum N.V. Organon, Nîderlande miorelaksants M03AC09 04-0205 Rpinjection 10 mg/ mlEuphyllinum, Solutio pro i.v. Theophyllinum, Moschimpharmpreparaty, bronholîtisks,asinsvadus R03DA04 00-0421 Rpinjectionibus 2,4 % 1,2-Etilendiaminum v.n. N.A.Semaðko, Krievija paplaðinoðs lîdzeklis 00-0422 RpEuphyllinum, Tabulettae 150 mg Theophyllinum, Etilendiaminum Moschimpharmpreparaty, bronholîtisks,asinsvadus R03DA04 00-0751 Rp

Krievija paplaðinoðs lîdzeklisExtractum Aloes fluidum pro Extractum Aloes Borisov Medical Preparation biogçns stimulators V03AX 00-1146 Rpinjectionibus, Solutio pro injectionibus 1 ml Plant, BaltkrievijaFaringosept, Tablets 10 mg Ambazonum Moschimpharmpreparaty/ antiseptisks lîdzeklis R02AA01 99-0653 Bezrecepðu

Terapia S.A., Krievija/RumânijaFebrex plus, Syrup Paracetamolum, Indoco Remedies Ltd, Indija pretsaaukstçðanâs lîdzeklis N02BE51 00-0847 Rp

Phenylpropanolaminum,Chlorpheniraminum

Page 19: Saturs Bßtiska informâcija

Fibrinogenum, Pulvis pro i.v. infusionibus Fibrinogenum humanum SIA �Baltijas Terapeitiskais koagulants B02BB01 95-0242 RpServiss�, Latvija

Flores Calendulae, Species Flores Calendulae Lektravi, JSC, Ukraina antiseptisks, pretiekaisuma V03AX 00-0076 Bezrecepðulîdzeklis

Flores Calendulae, Species Flores Calendulae SIA �Planta Medica Ltd.�, pretiekaisuma, þultsdzenoðs V03AX 99-0983 BezrecepðuLatvija lîdzeklis

Flores Chamomillae, Species Flores Chamomillae Lektravi, JSC, Ukraina pretiekaisuma, spazmolîtisks V03AX 00-0077 Bezrecepðulîdzeklis

Flores Chamomillae, Species Flores Chamomillae SIA �Planta Medica Ltd.�, antiseptisks, spazmolîtisks V03AX 99-0981 BezrecepðuLatvija lîdzeklis

Flores Helichrysi arenarii, Species Flores Helichrysi arenarii SIA �Planta Medica Ltd.�, þultsdzenoðs lîdzeklis A05A 00-0051 BezrecepðuLatvija

Folia Melissae, Species Folia Melissae SIA �Planta Medica Ltd.�, nomierinoðs, spazmolîtisks N05BX 00-0185 BezrecepðuLatvija lîdzeklis

Folia Menthae piperitae, Species Folia Menthae piperitae SIA �Planta Medica Ltd.�, spazmolîtisks, nomierinoðs A03 99-0980 BezrecepðuLatvija lîdzeklis

Folia Orthosiphonis staminei, Species Folia Orthosiphonis staminei Krasnogorskïeksredstva urîndzenoðs lîdzeklis C03 00-0873 BezrecepðuA/S, Krievija

Folia Salviae, Species Folia Salviae Lektravi, JSC, Ukraina pretiekaisuma, antiseptisks V03AX 00-0075 Bezrecepðulîdzeklis

Folia Uvae ursi, Species Folia Uvae ursi Lektravi, JSC, Ukraina pretiekaisuma, uroloìisks G04A 00-0199 Bezrecepðulîdzeklis

Folium Sennae, Species Folia Cassiae acutifoliae Lektravi, JSC, Ukraina caurejas lîdzeklis A06AB06 00-0643 BezrecepðuFormel 44 Husten-Loser, Syrup Guaifenesinum Procter&Gamble GmbH & atkrçpoðanas lîdzeklis R05CA03 96-0022 Bezrecepðu

Co Manufacturing OHG, VâcijaFructus Carvi, Species Fructus Carvi SIA �Planta Medica spazmolîtisks, karminatîvs A02X 00-0050 Bezrecepðu

Ltd.�, Latvija lîdzeklisFructus Rosae, Species Fructus Rosae SIA �Planta Medica vitamînu preparâts A11 00-0415 Bezrecepðu

Ltd.�, LatvijaFurosemidum, Solutio pro Furosemidum Borisov Medical Preparation diurçtisks lîdzeklis C03CA01 00-1210 Rpinjectionibus 1 % Plant, BaltkrievijaGardovit Multivitamin + Minerals Thiaminum, Riboflavinum, NP Pharma Sp.z.o.o., Polija polivitamîni ar A11AA03 01-0103 BezrecepðuOrange, Effervescent tablets Pyridoxinum, etc. minerâlvielâmGekkool, Oral liquid Gekko, Mel, Radix Morindae, Oriental Pharmaceutical vispârtonizçjoðs lîdzeklis V03AX 00-0842 Bezrecepðu

Fructus Chaenomelis lagenariae, Corporation 5 - FIDOPHARM,etc. Vjetnama

Gelictar Fort, Gel shampoo Extractum picis carboni, Laboratoires Mayoly dermatoloìisks lîdzeklis D11AC30 00-0834 BezrecepðuIchthyolum Spindler, Francija

Gelictar, Gel shampoo Extractum picis carboni, Laboratoires Mayoly dermatoloìisks lîdzeklis D11AC30 00-0833 BezrecepðuIchthyolum Spindler, Francija

Gemmae Pini, Species Gemmae Pini Lektravi, JSC, Ukraina atkrçpoðanu veicinoðs, R07AX 00-0762 Bezrecepðudezinficçjoðs lîdzeklis

Gentamycini sulfas, Solutio Gentamicini sulfas Moschimpharmpreparaty, antibiotisks lîdzeklis J01GB03 00-0081 Rppro injectionibus 4 % v.n. N.A.Semaðko, KrievijaGinseng Lingzhi Flo-Thru Tea, Species Lingzhi(Ganoderma lucidum), Central Pharmaceutical adaptogçns V03AX 00-0963 Bezrecepðu

Ginseng Radix, Herba Factory 26-OPC, VjetnamaCentellae, Herba Passiflorae

Glimestada 1 mg; 2 mg; 3 mg tablets, Glimepiridum Stada Arzneimittel AG, Vâcija pretdiabçta lîdzeklis A10BB12 05-0535 Rp05-0536 Rp05-0537 Rp

Glucosum, Solutio pro i.v. Dextrosum Borisov Medical Preparation ogïhidrâtu preparâts B05BA03 00-1145 Rpinjectionibus 40 % Plant, BaltkrievijaGuttae homeopathicae Arsenicum album, Lycopodium, Talion-A, Krievija pretalkoholisma lîdzeklis V03AX 00-1144 Bezrecepðu�Acidum S�, Guttae Nux vomica, Sulfur,

Acidum sulfuricumGuttae homeopathicae Chamomilla, Arnica, Talion-A, Krievija antivarikozs lîdzeklis V03AX 00-1143 Bezrecepðu�Iov-venum�, Guttae Lachesis, SulfurGuttae homeopathicae Thuja occidentalis, Aurum Talion-A, Krievija prostatoterapeitisks lîdzeklis V03AX 00-1142 Bezrecepðu�Thuja comp�, Guttae metallicum, Mercurius solubilisGuttae stomachicae, Guttae Tinct. Valerianae, Tinct. Ternopol Pharmaceutical nomierinoðs, spazmolîtisks V03AX 00-0529 Bezrecepðu

Belladonnae, Tinct. Menthae Plant, JSC, Ukraina lîdzeklispiperitae, Tinct. Absinthii

Guttae Zelenini, Liquor Tinct. Belladonnae, Tinct. Ternopol Pharmaceutical sirds lîdzeklis C01EX 99-0733 RpConvallariae, Tinct. Valerianae, Plant, JSC, UkrainaMentholum

Haematogenum, Tabella dividua Albuminum JSC �Belmedpreparat�, antiançmisks lîdzeklis, B06AB 99-0997 BezrecepðuBaltkrievija uztura papildinâtâjs

Haemodesum, Solutio pro infusionibus Polyvinylpyrrolidonum, JSC �Belmedpreparat�, dezintoksikants V03AX 00-0538 RpNatrii chloridum, etc. Baltkrievija

Hai Duong Bo Than, Oral liquid Hippocampus, Testis Capra sp., Oriental Pharmaceutical vispârtonizçjoðs lîdzeklis V03AX 00-0843 BezrecepðuHerba Epimedii, Semen Corporation 5 - FIDOPHARM,Cuscutae sinensis, etc. Vjetnama

Hartmann, Solution for infusion Natrii lactas, Natrii chloridum, Balkanpharma-Troyan izotonisks infûzijas ðíîdums B05BB01 97-0205 RpKalii chloridum, Calcii chloridum AD, Bulgârija

Herba Aervae lanatae, Species Herba Aervae lanatae Krasnogorskïeksredstva urîndzenoðs lîdzeklis C03 00-0872 BezrecepðuA/S, Krievija

Herba Alchemillae, Species Herba Alchemillae SIA �Planta Medica savelkoðs, asiòoðanu V03AX 99-0982 BezrecepðuLtd.�, Latvija apturoðs lîdzeklis

Herba Bidentis tripartitae, Species Herba Bidentis tripartitae SIA �Planta Medica Ltd.�, savelkoðs lîdzeklis V03AX 00-0413 BezrecepðuLatvija

Herba Bidentis tripartitae, Species Herba Bidentis tripartitae Lektravi, JSC, Ukraina pretiekaisuma, V03AX 00-0530 Bezrecepðusviedrçjoðs lîdzeklis

Herba Hyperici, Species Herba Hyperici SIA �Planta Medica antiseptisks, savelkoðs V03AX 00-0184 BezrecepðuLtd.�, Latvija lîdzeklis

Herba Millefolii, Species Herba Millefolii SIA �Planta Medica spazmolîtisks, V03AX 00-0183 BezrecepðuLtd.�, Latvija pretiekaisuma lîdzeklis

Zâïu valsts aìentûra Cito! � 3 (21) 19

Page 20: Saturs Bßtiska informâcija

20 Cito! � 3 (21) Zâïu valsts aìentûra

Histaglobulinum siccum, Histamini hydrochloridum, SIA �BaltijasTerapeitiskais imûnglobulînu J06BC 95-0203 RpPulvis pro injectionibus Immunoglobulinum Serviss�,Valsts Asinsdonoru grupas lîdzeklis

humanum normale Centrs, LatvijaHoneyed Korean Ginseng Extr. Ginsengi, Extr. Angelicae Pagin Biotech Co, Ltd., tonizçjoðs lîdzeklis A13 00-0281 BezrecepðuExtract Tea , Extract KorejaHospidermin, Losung Ethanolum absolutum, Kalium Lysoform Desinfection dezinfekcijas lîdzeklis D08AX 94-0209 Rp

rhodanatum, 5-chlor-acidum AG, Ðveicesalicylicum

Hospisept, Losung Propanolum, Lysoform Desinfection dezinfekcijas lîdzeklis D08AX53 94-0210 RpEthanolum absolutum AG, Ðveice

Human-Albumin 50; 200 �Dessau�, Albuminum humanum Pharma Dessau GmbH, Vâcija plazmas aizstâjçjs B05AA01 01-0054 RpSolution for infusion 5 %; 20 % 01-0055 RpHydrogenium peroxydatum 3 %, Hydrogenii peroxydum P.P.H. Aflopa, Polija antiseptisks lîdzeklis D08AX01 00-0548 BezrecepðuSolutio 3 %Hypaque Meglumine 60 %; 76 %, Acidum diatrizoicum, Nycomed Amersham Imaging Americas, ASV rentgenkontrastlîdzeklis V08AA0101-0145 01-0146 Rp RpSolution for i.v. injection MegluminumImmunoglobulinum humanum anti- Immunoglobulinum humanum SIA �Baltijas Terapeitiskais imûnglobulînu grupas J06BB01 95-0288 RpRhezus Rho(D), Solutio pro injectionibus anti-Rhezus Rho(D) Serviss�, Latvija lîdzeklisImmunoglobulinum humanum anti- Immunoglobulinum humanum SIA �BaltijasTerapeitiskais imûnglobulînu grupas J06BB08 95-0202 Rpstaphylococcum, Solutio pro injectionibus antistaphylococcum Serviss�,Valsts Asinsdonoru lîdzeklis

Centrs, LatvijaImmunoglobulinum humanum contra Immunoglobulinum humanum Biomed ,ZRA, Krievija imûnglobulînu grupas J06BB12 00-0524 Rpencephalitidem ioxodicum, lîdzeklisSolutio pro i.m. injectionibusImmunoglobulinum humanum contra Immunoglobulinum SIA �BaltijasTerapeitiskais imûnglobulînu grupas J06BB12 95-0167 Rpencephalitidem ixodicum, Serviss�,Valsts Asinsdonoru lîdzeklisSolutio pro injectionibus Centrs, LatvijaIndo 250, Tablets 250 mg Erythromycinum Indoco Remedies Ltd, Indija antibakteriâls lîdzeklis J01FA01 00-0957 RpInhalyptum, Aerosolum Sulfathiazolum natricum, Altajvitamini, JSC, Krievija antiseptisks, pretiekaisuma R02AB 00-0973 Bezrecepðu

Sulfanilamidum, Thymolum, etc. lîdzeklisIsodinit, Tablets 10 mg Isosorbidi dinitras Balkanpharma-Dupnitza antianginâls lîdzeklis C01DA08 97-0147 Bezrecepðu

AD, BulgârijaKorean Ginseng Youngji Extr. Ginsengi, Extr. Pagin Biotech Co, Ltd., alternatîvâs medicînas V03AX 99-0999 BezrecepðuGanodermae Koreja lîdzeklisExtract in capsule, CapsulaeKorean Ginseng Youngji Te, Granules Extr. Ginsengi, Extr. Pagin Biotech Co, Ltd., alternatîvâs medicînas V03AX 99-1000 Bezrecepðu

Ganodermae Koreja lîdzeklisKrashaemodesum, Polyvinylpyrrolidonum, Kraspharma, JSC, Krievija dezintoksikants V03AX 00-1139 RpSolutio pro infusionibus 6 % Natrii chloridum, etc.Kuka cough syrup, Syrup Radix Glycyrrhizae, Multani Pharm. Ltd, Indija tautas dziedniecîbas lîdzeklis R05CA 97-0425 Bezrecepðu

Ocimum sanctum, etc.Lactovaginal, Intravaginal globules Lactobacillus acidophilus Biomed S.A., Lab. for the ginekoloìisks lîdzeklis G02C 00-0549 Rp

Prod. of Sera and Vaccin, PolijaLaevomycetinum, Tabulettae Chloramphenicolum Moschimpharmpreparaty, antibakteriâls lîdzeklis J01BA01 00-0192 Rp

v.n. N.A.Semaðko, Krievija 00-0193 RpLaevomycetinum-KMP, Tabulettae 500 mg Chloramphenicolum A/S Kijevmedpreparat, Ukraina antibakteriâls lîdzeklis J01BA01 00-0532 RpLamoxy 250; 500, Capsulae Amoxycillinum Lyka Laboratories Ltd, Indija antibiotisks lîdzeklis J01CA04 00-0955 Rp

00-0956 RpLidocaini hydrochloridum 2 %, Lidocaini hydrochloridum A/S �Kalceks�, Latvija vietçjâs anestçzijas lîdzeklis N01BB02 95-0162 RpSolutio pro injectionibus 2 %Lidocainum, Solutio Lidocaini hydrochloridum Moschimpharmpreparaty, vietçji anestezçjoðs un N01BB02, 00-0875 Rppro injectionibus 2 %; 10% Krievija antiaritmisks lîdzeklis C01BB01 00-0876 RpLincomycini hydrochloridum, Lincomycini hydrochloridum Moschimpharmpreparaty, antibiotisks lîdzeklis J01FF02 00-0191 RpSolutio pro injectionibus 30 % v.n. N.A.Semaðko, KrievijaLincomycini hydrochloridum, Lincomycini hydrochloridum Borisov Medical Preparation antibiotisks lîdzeklis J01FF02 00-0426 RpSolutio pro injectionibus 30 % Plant, BaltkrievijaLiquor Ammonii anisatus, Anisi aetheroleum, Sol. A/S Rîgas farmaceitiskâ atkrçpoðanas lîdzeklis R05C 99-0677 BezrecepðuLiquor ad usum internum Ammonii caustici fabrika, LatvijaLiv. 52, Syrup Capparia spinosa, Cichorium The Himalaya Drug Co., Indija hepatoterapeitisks lîdzeklis A05BA 01-0033 Rp

intybus, Solanum nigrum, etc.Liv. 52, Drops Capparia spinosa, Cichorium The Himalaya Drug Co., Indija hepatoterapeitisks lîdzeklis A05BA 01-0032 Rp

intybus, Solanum nigrum, etc.Liv. 52, Tablets Capparia spinosa, Cichorium The Himalaya Drug Co., Indija hepatoterapeitisks lîdzeklis A05BA 01-0031 Bezrecepðu

intybus, Solanum nigrum, etc.Long Chi Bo Gan Lo, Oral liquid Folium Cynarae, Gentiana Oriental Pharmaceutical vispârtonizçjoðs lîdzeklis V03AX 00-0841 Bezrecepðu

scabra Bunge, etc. Corporation 5 - FIDOPHARM,Vjetnama

Loratadine Mepha-10 mg, Tablets Loratadinum Mepha Lda., Portugâle prethistamîna lîdzeklis R06AX13 04-0224 BezrecepðuMajor Brand Quality Tri-Buffered Acidum acetylsalicylicum Major Pharmaceuticals, nesteroidâls pretiekaisuma N02BA01 94-0207 BezrecepðuAspirin, Tablets 325 mg Inc., ASV lîdzeklisMajor Quality Aspirin Analgesic Acidum acetylsalicylicum Major Pharmaceuticals, pretsâpju, pretdrudþa N02BA01 94-0206 BezrecepðuTablets, Tablets 325 mg Inc., ASV lîdzeklisMemory Supporter �Your Life�, Tablets Cyanocobalaminum, Leiner Health Products, cerebrâlo asinsriti N06BX19 00-0597 Bezrecepðu

Phosphatidylserinum, etc. Inc., ASV uzlabojoðs lîdzeklisMenovasinum, Solutio Mentholum, Procainum, Ternopol Pharmaceutical pretsâpju lîdzeklis M02AX10 00-0528 Bezrecepðu

Anaesthesinum Plant, JSC, UkrainaMesporin- 2000 I.V., Powder for injection Ceftriaxonum Mepha Lda., Portugâle antibiotisks lîdzeklis J01DD04 02-0399 RpMesporin-250 I.M. ;500 I.M., Ceftriaxonum Mepha Lda., Portugâle antibiotisks lîdzeklis J01DD04 02-0397 RpPowder for injection + solvent 02-0398 RpMetronidazole Injection USP, Metronidazolum Wockhardt Ltd, Indija pretmikrobu lîdzeklis J01XD01 97-0610 RpSolution for i.v. injectionMonocline 100 mg, Coated tablets Doxycyclinum Lab. Doms-Adrian, Francija antibiotisks lîdzeklis J01AA02 01-0074 RpMoxypen Amoxycillin 250 mg/ 5 ml Amoxicillinum Teva Pharma B.V., Nîderlande antibiotisks lîdzeklis J01CA04 99-0972 Rpsuspension, Powder for suspension250 mg/ 5 ml

Page 21: Saturs Bßtiska informâcija

Moxypen Amoxycillin capsules Amoxicillinum Teva Pharma B.V., Nîderlande antibiotisks lîdzeklis J01CA04 99-0568 Rp500 mg, CapsulaeMucalthinum, Tabulettae 0,05 g Natrii hydrocarbonas, JSC �Galychpharm�, Ukraina atkrçpoðanas lîdzeklis R05CA 00-0060 Bezrecepðu

Mucaltinum (Folium Althaeae)Mucofalk apple, Granules Testa Plantaginis ovatae Dr. Falk Pharma GmbH, Vâcija caurejas lîdzeklis A06A 01-0114 BezrecepðuMucosol 250, Syrup 250 mg/ 5 g Carbocysteinum CTS Chemical Industries mukolîtisks lîdzeklis R05CB03 00-0156 Rp

Ltd, IzraçlaMucosol 375, Capsulae 375 mg Carbocysteinum CTS Chemical Industries mukolîtisks lîdzeklis R05CB03 00-0157 Rp

Ltd, IzraçlaMyofedrin, Tablets 16 mg Oxyfedrinum Apogepha Arzneimittel koronâros asinsvadus C01DX03 99-0414 Rp

GmbH, Vâcija paplaðinoðs lîdzeklisNalgesin forte, Film-coated tablets 550 mg Naproxenum KRKA, Slovçnija nesteroidâls pretiekaisuma M01AE02 01-0090 Rp

lîdzeklisNalgesin S, Film-coated tablets 275 mg Naproxenum KRKA, Slovçnija nesteroidâls pretiekaisuma M01AE02 01-0089 Rp

lîdzeklisNatrii adenosintriphosphatum 1 %, Natrii adenosintriphosphas Borisov Medical Preparation audu vielmaiòu A16AX 00-0318 RpSolutio pro injectionibus Plant, Baltkrievija veicinoðs lîdzeklisNatrii thiosulfas 30 %, Solutio Natrii thiosulfas A/S �Kalceks�, Latvija antidots V03AB06 95-0241 Rppro injectionibus 30 %Nifuroksazyd 100 mg, Coated tablets Nifuroxazidum Grodzinsk Pharmaceutical pretcaurejas lîdzeklis A07AX03 00-1067 Rp

Works �Polfa�, PolijaNitrosorbidum-UVI, Tabulettae 10 mg Isosorbidi dinitras A/S �Ufavita�, Krievija antianginâls lîdzeklis C01DA08 00-0631 BezrecepðuNitroxolinum, Tabulettae 0,05 g Nitroxolinum Umaòas AS �Vitamîni�, antibakteriâls lîdzeklis J01XX07 00-1053 Rp

UkrainaNovocainamidum, Solutio pro Procainamidum Moschimpharmpreparaty, antiaritmisks lîdzeklis C01BA02 00-0194 Rpinjectionibus 10 % v.n. N.A.Semaðko, KrievijaNystatinum, Tabulettae obductae 500 000 UNystatinum JSC �Belmedpreparat�, pretsçnîðu lîdzeklis A07AA02 00-0644 Rp

BaltkrievijaNystatinum, Tabulettae obductae 500 000 UNystatinum Borisov Medical Preparation pretsçnîðu lîdzeklis A07AA02 00-1057 Rp

Plant, BaltkrievijaOleum Hippophaes, Liquid Oleum Hippophaeae Altajvitamini, JSC, Krievija spazmolîtisks lîdzeklis A11JC 00-0308 BezrecepðuOlexar 5 mg; 10 mg , tablets Olanzapinum SIA Unifarma, Latvija antipsihotisks lîdzeklis N05AH03 05-0358 Rp

05-0359 RpOlfen-25 Lactab, Film-coated gastric- Diclofenacum natricum Mepha Lda., Portugâle nesteroidâls pretiekaisuma M01AB05 93-0568 Rpresistant tablets 25 mg lîdzeklisOrtophenum, Tabulettae obductae 0,025 g Diclofenacum natricum Moschimpharmpreparaty, nesteroidâls pretiekaisuma M01AB05 00-0749 Rp

Krievija lîdzeklisOvestin, Vaginal cream 1 mg/ g Estriolum Organon (Ireland) Ltd., Îrija estrogçns lîdzeklis G03CA04 97-0496 RpOxydevitum, Solutio spirituosa 0,00125 % Alfacalcidolum FARMA BALT SIA, Latvija D3 vitamîna preparâts A11CC03 93-0496 RpPanax-A Korean Ginseng Extract, Extr. Ginsengi, Pollen, Pagin Biotech Co, Ltd., tonizçjoðs lîdzeklis A13 00-0158 BezrecepðuCapsule Royal Jelly KorejaPancreatinum, Tabulettae Pancreatinum Vitamîni, Umaòas R/A, fermentu preparâts A09AA 00-0431 Bezrecepðuenterosolubiles 0,25 g UkrainaPapaverini hydrochloridum, Papaverini hydrochloridum Borisov Medical Preparation spazmolîtisks lîdzeklis A03AD01 00-0317 RpSolutio pro injectionibus 2 % Plant, BaltkrievijaPapazolum, Tabulettae Dibazolum, Papaverini Moschimpharmpreparaty, spazmolîtisks lîdzeklis A03AD 00-0304 Bezrecepðu

hydrochloridum v.n. N.A.Semaðko, KrievijaPapazolum, Tabulettae Dibazolum, Borisov Medical Preparation spazmolîtisks lîdzeklis A03AD 00-0319 Rp

Papaverini hydrochloridum Plant, BaltkrievijaParacet for infants, Suspension Paracetamolum Sagmel, Inc., ASV pretsâpju, pretdrudþa N02BE01 00-1123 Bezrecepðudrops 80 mg/ 0,8 ml lîdzeklisParacetamolum, Tabulettae 0,5 g Paracetamolum Moschimpharmpreparaty, pretsâpju, pretdrudþa N02BE01 99-0468 Bezrecepðu

v.n. N.A.Semaðko, Krievija lîdzeklisParacetamolum, Tabulettae 200 mg Paracetamolum Borisov Medical Preparation pretdrudþa lîdzeklis N02BE01 00-0429 Bezrecepðu

Plant, BaltkrievijaPasta Teimurovi, Pasta Acidum boricum, Natrii Ternopol Pharmaceutical dermatoloìisks lîdzeklis D02AX 00-0430 Bezrecepðu

tetraboras, Acidum salicylicum, Plant, JSC, UkrainaZinci oxidum

Pavulon 4 mg = 2 ml, Pancuronii bromidum N.V. Organon, Nîderlande miorelaksants M03AC01 04-0202 RpSolution for injection 4 mg/ 2 mlPentalginum, Tabulettae Metamizolum, Paracetamolum, JSC �Belmedpreparat�, pretsâpju lîdzeklis N02BB52 00-1059 Rp

Coffeinum, Codeinum, BaltkrievijaPhenobarbitalum

Pentalginum-N, Tabulettae Metamizolum, Naproxenum, JSC �Belmedpreparat�, pretsâpju lîdzeklis N02BB52 00-0537 RpCoffeinum, Phenobarbitalum, BaltkrievijaCodeinum

Phong Thap Thuy, Oral liquid Rhizoma Homalomenae, Oriental Pharmaceutical alternatîvâs medicînas V03AX 00-0736 BezrecepðuRadix Stephaniae, Cortex Corporation 5 - FIDOPHARM, lîdzeklisCinnamomi, etc. Vjetnama

Phthalazolum-KMP, Tabulettae 0,5 g Sulfathiazolum A/S Kijevmedpreparat, Ukraina antibakteriâls lîdzeklis J01EB07 00-0766 RpPiroxicam NIHFI, Capsulae 20 mg Piroxicamum Chem.Pharm.Research nesteroidâls pretiekaisuma M01AC01 98-0678 Rp

Institute - NIHFI Ltd, lîdzeklisBulgârija

Plecidrex, Tablets Hydrochlorothiazidum, Plethico Pharmaceuticals antihipertensîvs lîdzeklis C02LA01 00-0950 RpDihydralazinum, Reserpinum Ltd, Indija

Plestal, Enteric-coated tablets Lipasum, Proteasum, Plethico Pharmaceuticals fermentu preparâts A09AA02 00-0860 BezrecepðuAmilasum, etc. Ltd, Indija

Polybiolinum, Pulvis pro injectionibus Polybiolinum SIA �Baltijas Terapeitiskais biostimulators, B05AA 95-0286 RpServiss�, Latvija pretiekaisuma lîdzeklis

Polyglucinum, Solution for i.v. infusion Dextranum JSC �Belmedpreparat�, plazmas aizstâjçjs B05AA05 00-0422 RpBaltkrievija

Polyglucinum, Solution for infusion Dextranum Kraspharma, JSC, Krievija plazmas aizstâjçjs B05AA05 00-1209 RpPrednisolonum, Tabulettae 0,005 g Prednisolonum Moschimpharmpreparaty, glikokortikosteroîds H02AB06 00-1138 Rp

KrievijaPremenstrual Pain Relief tablets, Tablets Paracetamolum, Contract Pharmacal pretsâpju lîdzeklis N02BE51 00-1126 Bezrecepðu

Phenyltoloxamini citras Corporation, ASV

Zâïu valsts aìentûra Cito! � 3 (21) 21

Page 22: Saturs Bßtiska informâcija

22 Cito! � 3 (21) Zâïu valsts aìentûra

Proserinum, Solutio Neostigmini methylsulfas Moschimpharmpreparaty, antiholînesterâzes lîdzeklis N07AA01 00-0753 Rppro injectionibus 0,05 % KrievijaPyridoxini hydrochloridum, Pyridoxini hydrochloridum Moschimpharmpreparaty, vitamînu preparâts A11HA02 00-0303 RpSolutio pro injectionibus 5 % v.n. N.A.Semaðko, KrievijaPyridoxini hydrochloridum, Pyridoxini hydrochloridum Borisov Medical Preparation vitamînu preparâts A11HA02 01-0005 RpSolutio pro injectionibus 5 % Plant, BaltkrievijaRanitidin, Coated tablets 150 mg; 0,15 g Ranitidinum Chem.Pharm.Research pretèûlas lîdzeklis, H2- A02BA02 99-0462 Rp

Institute - NIHFI Ltd, Bulgârija receptoru blokators 99-0467 RpRaunatinum, Tabulettae obductae 0,002 g Raunatinum Moschimpharmpreparaty, v.n. antihipertensîvs lîdzeklis C02AA03 00-0305 Rp

N.A.Semaðko, KrievijaRemantadîna sîrups, Syrup 10 mg/ 5 ml Rimantadini hydrochloridum A/S Olaines íîmiski- pretvîrusu lîdzeklis J05AC02 00-1035 Rp

farmaceitiskâ rûpnîca�Olainfarm�, Latvija

Reopolyglucinum, Solutio Dextranum Kraspharma, JSC, Krievija plazmas aizstâjçjs B05AA05 01-0044 Rppro infusionibus 10 %Retinoli acetas, Solutio oleosa Retinoli acetas JSC �Belmedpreparat�, vitamînu preparâts A11CA01 00-0425 Rpin capsulis 33 000 IU BaltkrievijaRevitum, Dragee Acidum ascorbicum, Retinoli Kievskiy vitaminiy zavod, polivitamînu preparâts A11AB 00-1050 Bezrecepðu

palmitas, Thiaminum, JSC, UkrainaRiboflavinum

Rheopolyglucinum, Solutio Dextranum JSC �Belmedpreparat�, plazmas aizstâjçjs B05AA05 00-0200 Rppro i.v. injectionibus BaltkrievijaRheopolyglucinum cum glucoso, Dextranum, Glucosum JSC �Belmedpreparat�, plazmas aizstâjçjs B05AA05 00-0201 RpSolutio pro i.v. injectionibus BaltkrievijaRhizomata cum radicibus Rhizoma cum radicibus SIA �Planta Medica Ltd.�, nomierinoðs lîdzeklis N05CM09 00-0045 BezrecepðuValerianae, Species Valerianae LatvijaRiboxinum, Capsulae 0,2 g Inosinum JSC �Minskintercaps�, sirds lîdzeklis C01EB 00-0204 Rp

BaltkrievijaRiboxinum, Tabulettae obductae 0,2 g Inosinum JSC �Belmedpreparat�, sirds lîdzeklis C01EB 00-0203 Rp

BaltkrievijaRiboxinum, Tabulettae obductae 0,2 g Inosinum Borisov Medical Preparation sirds lîdzeklis C01EB 00-0315 Rp

Plant, BaltkrievijaRiboxinum, Tabulettae obductae 0,2 g Inosinum Tathimfarmpreparati, Krievija sirds lîdzeklis C01EB 99-0737 RpSalbutamolum, Aerosolum Salbutamolum Moschimpharmpreparaty, pretastmas lîdzeklis R03AC02 00-0078 Rp

v.n. N.A.Semaðko, KrievijaSam Nhung Kien Luc, Oral liquid Cornu Cervi parvum, Cornu Oriental Pharmaceutical alternatîvâs medicînas V03AX 00-0734 Bezrecepðu

Cervi, Radix Campanumoeae, Corporation 5 - FIDOPHARM, lîdzeklisetc. Vjetnama

Sam Qui Tinh, Oral solution Rad. Angelicae sinensis, Rad. The Oriental Pharm. Factory alternatîvâs medicînas V03AX 00-0399 BezrecepðuCampanumoceae, Rad. of the 5th distr.HCM, lîdzeklisSatragali, Rad. Morindae, etc. Vjetnama

Semina Lini, Species Semina Lini Lektravi, JSC, Ukraina gastroenteroloìisks A02X 00-1214 Bezrecepðupretiekaisuma lîdzeklis

Sibazonum 0,5 %, Solutio Diazepamum A/S �Kalceks�, Latvija trankvilizators N05BA01 95-0354 Rppro injectionibus 0,5 %Sigman-Haustropfen, Solution Ol. Menthae piperitae, Ol. Sigmapharm Arzneimittel gremoðanu veicinoðs A16AX 01-0139 Bezrecepðu

Cavi, D-panthenolum, etc. GmbH & Co. KG, Austrija lîdzeklisSinapismus-Saccinus, Emplastrum Extr. Semen Sinapis Sarepta, OJSC, Krievija kairinoðs lîdzeklis V03AX 00-0088 BezrecepðuSliced Korean Ginseng Honeyed, Pastilles Ginseng Radix Pagin Biotech Co, Ltd., alternatîvâs medicînas V03AX 00-0282 Bezrecepðu

Koreja lîdzeklisSol. Atropini sulfatis 0,1 % pro Atropini sulfas Pilot Plant of SSCD, Ukraina spazmolîtisks lîdzeklis A03BA01 99-0745 Rpinjectionibus, Solutio pro injectionibus0,1 %Solutio Alfa-Tocopheroli acetatis Tocopheroli acetas JSC �Minskintercaps�, vitamînu preparâts A11HA03 00-0534 Rp(Vitamini E) oleosa 50 %, Capsulae Baltkrievija 00-0535 Rp50 mg; 100 mg; 200 mg 00-0536 RpSolutio Iodi spirituosa 5 %, Solutio 5 % Iodum, Kalii iodidum Ternopol Pharmaceutical antiseptisks lîdzeklis D08AG 99-0919 Bezrecepðu

Plant, JSC, UkrainaSolutio Laevomycetini 0,25 %, Chloramphenicolum Endokrinininai antibiotisks lîdzeklis S01AA01 99-0493 RpGuttae ophthalmicae Preparatai, LietuvaSolutio Natrii chloridi isotonica 0,9 %, Natrii chloridum Borisov Medical Preparation sâls preparâts B05XA03 00-1211 RpSolutio pro injectionibus 0,9 % Plant, BaltkrievijaSolutio Promedoli 1 %; 2 %, Trimeperidini hydrochloridum MASKAVAS ENDOKRÎNÂ narkotisks analgçtisks N02AB 00-0416 Rp ISolutio pro injectionibus 1 % RÛPNÎCA, Krievija lîdzeklis 00-0417 Rp ISolutio Retinoli acetatis oleosa, Retinoli acetas JSC �Minskintercaps�, vitamînu preparâts A11CA01 00-0533 RpCapsulae 33 000 IU BaltkrievijaSolutio Riboxini 2 % pro injectionibus, Inosinum Borisov Medical Preparation sirds lîdzeklis C01EB 00-0316 RpSolutio pro injectionibus 2 % Plant, BaltkrievijaSolutio Viridis nitentis Viride nitens Ternopol Pharmaceutical antiseptisks lîdzeklis D08AX 00-0527 Bezrecepðuspirituosa 1 %, Solutio 1 % Plant, JSC, UkrainaSpecies Cholagogae N2, Species Flores Helichrysi, Herba Krasnogorskïeksredstva þultsdzenoðs lîdzeklis A05AX 01-0042 Bezrecepðu

Millefolii, etc. A/S, KrievijaSpecies Cholagogae N3, Species Flores Chamomillae, Folia Krasnogorskïeksredstva þultsdzenoðs lîdzeklis A05AX 00-1041 Bezrecepðu

Menthae piperitae, etc. A/S, KrievijaSpecies Gastrointestinales, Species Flores Chamomillae, Folia Krasnogorskïeksredstva spazmolîtisks, V03AX 00-0874 Bezrecepðu

Menthae piperitae, etc. A/S, Krievija pretiekaisuma lîdzeklisSpecies Pectorales N4, Species Flores Chamomillae, Cormus Krasnogorskïeksredstva pretklepus lîdzeklis R05CA10 01-0043 Bezrecepðu

Ledi palustris, etc. A/S, KrievijaSpecies Pectorales Nr.1, Species Radix Althaeae, Folium Lektravi, JSC, Ukraina atkrçpoðanu veicinoðs R05CA10 00-0763 Bezrecepðu

Farfarae, Herba Origani lîdzeklisSpecies Pectorales Nr.2, Species Folium Farfarae, Folium Lektravi, JSC, Ukraina atkrçpoðanu veicinoðs R05CA10 00-0764 Bezrecepðu

Plantaginis majoris, lîdzeklisRadix Glycyrrhizae

Species Urologicae (diureticae), Species Folia Uvae ursi, Flores Krasnogorskïeksredstva urîndzenoðs lîdzeklis G04BX 00-1140 BezrecepðuCalendulae, Fructus Anethi, etc. A/S, Krievija

Page 23: Saturs Bßtiska informâcija

Species Urologicae (diureticae), Folia Uvae ursi, Flores Krasnogorskïeksredstva urîndzenoðs lîdzeklis G04BX 00-1141 BezrecepðuSpecies 2 g Calendulae, Fructus Anethi, etc. A/S, KrievijaStress 500 with Zinc, Tablets Acidum ascorbicum, Contract Pharmacal polivitamînu preparâts A11AA04 00-1125 Bezrecepðu

Tocopheroli acetas, etc. Corporation, ASV ar cinkuStrophanthinum K, Solutio Strophanthinum K JSC �Galychpharm�, Ukraina sirds glikozîds C01AC 99-0800 Rppro injectionibus 0,025 %Subutex 0,4mg; 2 mg, Sublingual tablets Buprenorphini hydrochloridum Schering-Plough Europe, opioîdu atkarîbas N07BC01 03-0265 Rp

Beïìija ârstçðanas lîdzeklis 03-0266 RpSubutex 8 mg, Sublingual tablets Buprenorphini hydrochloridum Schering-Plough Europe, opioîdu atkarîbas N07BC01 03-0267 Rp

Beïìija ârstçðanas lîdzeklisSulfacylum-natrium, Guttae Sulfacetamidum, JSC �Belmedpreparat�, antibakteriâls lîdzeklis S01AB04 00-0073 Bezrecepðuophthalmicae 20 % Natrii thiosulfas BaltkrievijaSupradyn, Coated tablets Vit. A, Vit. B1, Vit. B2, Vit. F.Hoffmann-La Roche polivitamîni ar A11AA03 00-1190 Bezrecepðu

B6, Vit. B12, Vit. C, etc. Ltd., Ðveice minerâlvielâmSydnopharm, Tablets 2 mg Molsidominum Chem.Pharm.Research antianginâls lîdzeklis C01DX12 99-0083 Rp

Institute - NIHFI Ltd, BulgârijaTabulettae �Ascorutinum�, Tabulettae Rutinum, Acidum ascorbicum Kievskiy vitaminiy zavod, vitamînu preparâts A11JC 00-0526 Bezrecepðu

JSC, UkrainaTabulettae Acidi ascorbinici 0,025 g Acidum ascorbicum Kievskiy vitaminiy zavod, vitamînu preparâts A11GA01 99-0495 Bezrecepðucum saccharo, Tabulettae 0,025 g JSC, UkrainaTabulettae Ampicillini trihydratis Ampicillinum trihydricum Kharkiv Pharmaceutical Firm antibiotisks lîdzeklis J01CA01 99-0918 Rp0,25 g, Tabulettae 0,25 g � Zdorovya �, UkrainaTabulettae Clophelini 0,00015 g, Clonidinum Farmak, JSC, Ukraina antihipertensîvs lîdzeklis C02AC01 00-1049 RpTabulettae 0,00015 gTabulettae Clophelini 0,00015 g; Clonidini hydrochloridum Luganskas ÍFR, Ukraina antihipertensîvs lîdzeklis C02AC01 99-0490 Rp0,000075 g, Tabulettae 99-0491 RpTabulettae contra tussim, Tabulettae Herba Thermopsidis Tathimfarmpreparati, Krievija atkrçpoðanas lîdzeklis R05CA 99-0736 BezrecepðuTabulettae Ibuprofeni obductae, Ibuprofenum Tathimfarmpreparati, nesteroidâls pretiekaisuma M01AE01 99-0496 BezrecepðuTabulettae obductae 0,2 g Kazaòas ÍFRA, Krievija lîdzeklisTabulettae Laevomycetini 0,5 g, Chloramphenicolum Kievskiy vitaminiy zavod, antibakteriâls lîdzeklis J01BA01 00-0525 RpTabulettae JSC, UkrainaThalli Laminariae, Species Thalli Laminariae Krasnogorskïeksredstva caurejas lîdzeklis A06A 00-1042 Bezrecepðu

A/S, KrievijaThap Toan Dai Bo, Oral liquid Rad. Angelicae sinensis, Oriental Pharmaceutical alternatîvâs medicînas V03AX 00-0602 Bezrecepðu

Radix Codonopsis pilosulae, etc. Corporation 5 - FIDOPHARM, lîdzeklisVjetnama

Theophedrinum - N, Tabulettae Paracetamolum, Theophyllinum, Moschimpharmpreparaty, bronholîtisks lîdzeklis R03DA54 99-0487 RpPhenobarbitalum, etc. v.n. N.A.Semaðko, Krievija

Thuoc Ho Nguoi Lon, Oral liquid Amygdalis communis, Radix Oriental Pharmaceutical alternatîvâs medicînas V03AX 00-0604 BezrecepðuPlatycodi, Radix Stemonae, Corporation 5 - FIDOPHARM, pretklepus lîdzeklisHerba Menthae, etc. Vjetnama

Thuoc Ho Tre Em, Oral liquid Amygdalis communis, Radix Oriental Pharmaceutical alternatîvâs medicînas V03AX 00-0603 BezrecepðuPlatycodi, Radix Stemonae, Corporation 5 - FIDOPHARM, pretklepus lîdzeklisHerba Menthae, etc. Vjetnama

Thyreoidinum, Tabulettae obductae 0,1 g Thyreoidinum A/S �Belmedpreparati�, hormonu preparâts H03AA05 00-0202 RpBaltkrievija

Tien Nu Cao, Oral liquid Herba Leonuri, Herba Oriental Pharmaceutical alternatîvâs medicînas V03AX 00-0735 BezrecepðuArtemisiae vulgaris, Rhizoma Corporation 5 - FIDOPHARM, lîdzeklisCyperi, etc. Vjetnama

Tinctura Calendulae, Tinctura Flores Calendulae Ternopol Pharmaceutical antiseptisks, pretiekaisuma D08AX 99-0735 BezrecepðuPlant, JSC, Ukraina lîdzeklis

Tinctura Chelidonii, Tinctura 1 : 10 Herba Chelidonii SIA �Leopolds�, Latvija pretiekaisuma, antiseptisks V03AX 00-0624 Bezrecepðulîdzeklis

Tinctura Ginseng, Tinctura Ginseng Radix Borisov Medical Preparation tonizçjoðs lîdzeklis A13 00-1058 RpPlant, Baltkrievija

Tinctura Propolisi, Tinctura Propolis Borisov Medical Preparation pretiekaisuma lîdzeklis D08AX 00-1149 RpPlant, Baltkrievija

Tinctura Valerianae, Tinctura Radix Valerianae Ternopol Pharmaceutical sedatîvs lîdzeklis N05CM09 99-0734 BezrecepðuPlant, JSC, Ukraina

Triam-co Tablets, Tablets 25 mg/ 50 mg Hydrochlorothiazidum, Norton Healthcare diurçtisks lîdzeklis C03EA01 99-0819 RpTriamterenum Ltd, Lielbritânija

Trimadiaz Antrima, Tablets 400/ 80 mg Sulfadiazinum, Trimethoprimum Lab. Doms-Adrian, Francija antibakteriâls lîdzeklis J01EE02 99-0612 RpTrimovax Merieux, Powder and diluent Vaccinum morbillorum vivum, Aventis Pasteur S.A., Francija kombinçta vakcîna pret J07BD52 96-0044 Rpfor solution for injection Vaccinum parotitidis vivum, masalâm, masaliòâm

Vaccinum rubellae vivum un parotîtuTrirezid K, Tabulettae obductae Reserpinum, Moschimpharmpreparaty, antihipertensîvs lîdzeklis C02LA51 00-0877 Rp

Hydrochlorothiazidum, KrievijaDihydralazini sulfas, Kaliichloridum

Triz, Tablets 10 mg Cetirizini hydrochloridum Indoco Remedies Ltd, Indija prethistamîna lîdzeklis R06AE07 00-1135 RpTusidil, Sugar coated tablets 40 mg Glaucini phosphas Jaka 80 AD, Maíedonija pretklepus lîdzeklis R05DB 00-1119 RpTusidil, Syrup for adults 40 mg/ 15 ml Glaucini phosphas Jaka 80 AD, Maíedonija pretklepus lîdzeklis R05DB 00-1121 RpTusidil, Syrup for children 5 mg/ 5 ml Glaucini phosphas Jaka 80 AD, Maíedonija pretklepus lîdzeklis R05DB 00-1120 RpTuspel plus cough syrup, Syrup Bromhexini hydrochloridum, Indoco Remedies Ltd, Indija pretklepus lîdzeklis R05CB10 00-0848 Bezrecepðu

Salbutamoli sulfas, Mentholum,Ammonii chloridum

Twice-A-Day 12 Hour Nasal Spray, Spray Oxymetazolini hydrochloridum Major Pharmaceuticals, pretiesnu lîdzeklis R01AA05 95-0080 BezrecepðuInc., ASV

Tyzine 0,05 %, Nose drops Tetryzolini hydrochloridum Pfizer Consumer Healthcare, pretiesnu lîdzeklis R01AB03 97-0436 Bezrecepðufor children 0,05 % LielbritânijaTyzine 0,1 %, Nose drops 0,1 % Tetryzolini hydrochloridum Pfizer Consumer Healthcare, pretiesnu lîdzeklis R01AB03 97-0435 Bezrecepðu

LielbritânijaUnguentum Acidi borici 5 %, Acidum boricum A/S Rîgas farmaceitiskâ antiseptisks lîdzeklis D08AD 99-0162 BezrecepðuUnguentum 5 % fabrika, Latvija

Zâïu valsts aìentûra Cito! � 3 (21) 23

Page 24: Saturs Bßtiska informâcija

Mainîts zâïu nosaukumsZâïu nosaukums mainîts

Reìistrâcijas apliecîbas Reìistrâcijas numurs LRNo Uz Îpaðnieks zâïu reìistrâ

Sol.Natrii chloridi 0,9% Solutio pro Sodium chloride Ilsanta 0,9 % UAB Ilsanta,Lietuva 96-0312 infusionibus 0,9% ðíîdums infûzijâm, irigâcijâm

Setronon injection 4 mg/2 ml; Ondansetron Pliva 4 mg/2 ml; PLIVA Krakow, Pharmaceutical 04-01568 mg/4 ml 8 mg/4 ml Company, Polija 04-0157

Tafen Nasal Budesonid Sandoz LEK Pharmaceuticals d.d., 02-0043 Slovçnija

Ketoprom 25 mg/g gel Spinax 25 mg/g gel GlaxoSmithKline Latvia SIA, 05-0590Latvija

Flixonase Nasal Drops Flixonase� Nasule� Drops Glaxo Wellcome Operations Ltd., 02-0266Lielbritânija

Unguentum Lariphani 0,05 %, Acidum ribonucleinicum SIA �Larifâns�, Latvija pretvîrusu lîdzeklis, D06BB 94-0070 BezrecepðuUnguentum 0,05 % duplicatum interferona induktorsUrolesan, Drops Ol. Pini, Ol. Menthae piperitae, JSC �Galychpharm�, spazmolîtisks, G04B 00-0059 Bezrecepðu

Ol. Ricini, Extr. Strobuli Lupuli, Ukraina diurçtisks lîdzeklisExtr. Origani, Extr. Dauci

Veragamma 240 , Retard tablets 240 mg Verapamili hydrochloridum Worwag Pharma GmbH & kalcija kanâlu blokators C08DA01 01-0199 RpCo.KG, Vâcija

Veragamma 40; 80, Coated tablets Verapamili hydrochloridum Worwag Pharma GmbH & kalcija kanâlu blokators C08DA01 01-0197 Rp40 mg; 80 mg Co.KG, Vâcija 01-0198 RpVerapamil NIHFI, Coated tablets 40 mg Verapamili hydrochloridum Chem.Pharm.Research kalcija kanâlu blokators C08DA01 99-0360 Rp

Institute - NIHFI Ltd, BulgârijaVerapamil, Solution for Verapamili hydrochloridum Belupo Ltd, Horvâtija kalcija kanâlu blokators C08DA01 00-0446 Rpinjection 5 mg/ 2 mlVibramycin, Capsules 100 mg Doxycyclinum Pfizer H.C.P., ASV antibiotisks lîdzeklis J01AA02 96-0602 RpVicairum Tabulettae, Tabulettae Bismuthi subnitras, Magnesii c JSC �Galychpharm�, Ukraina antacîds lîdzeklis A02BX 99-0798 Bezrecepðu

arbonas, etc.Vicalinum, Tabulettae Bismuthi subnitras, Natrii JSC �Galychpharm�, Ukraina antacîds lîdzeklis A02BX 99-0797 Bezrecepðu

hydrocarbonas, etc.,Vikasolum, Solutio pro injectionibus 1% Menadionum Moschimpharmpreparaty, antihemoraìisks lîdzeklis, B02BA02 00-1206 Rp

Krievija K vitamîna preparâtsVikasolum, Tabulettae 0,015 g Menadionum Moschimpharmpreparaty, antihemoraìisks lîdzeklis, B02BA02 00-0974 Rp

Krievija K vitamîna preparâtsVita Drops with Iron, Liquid Retinoli acetas, Major Pharmaceuticals, polivitamîni ar dzelzi A11AA01 98-0198 Bezrecepðu

Ergocalciferolum, etc. Inc., ASVXantinoli nicotinas 15 %, Xantinoli nicotinas A/S �Kalceks�, Latvija cerebrâlo un perifçro C04AD02 99-0167 RpSolutio pro injectionibus asinsriti uzlabojoðs lîdzeklisXantinoli nicotinas, Tabulettae 150 mg Xantinoli nicotinas Galychpharm, JSC, Ukraina perifçriskos asinsvadus C04AD02 00-0637 Rp

paplaðinoðs lîdzeklis

Zâïu valsts aìentûras (direktore I. Adovièa) izdevums.Reìistrçts Latvijas Republikas Tieslietu ministrijas Uzòçmumu reìistrâ. Reìistrâcijas apliecîba: M000386.Redakcijas kolçìija: Vija Berlande (galv. redaktore), Dr. Zane Neikena (redaktore), Dr. Inguna Adovièa, Dr. hab. med. Jânis Baltkâjs,asoc. prof. V. Fatejevs, Dr. Inâra Rubene, Dr. Inese Studere.Literârais redaktors Jânis Loja. Tulkotâja Inga Palma. Datorsalicçjs Uìis Desmitnieks.Tirâþa 5000. Iznâk reizi divos mçneðos.Bezmaksas izdevums.

Redakcijas adrese: Jersikas iela 15, Rîga, LV�1003, Rîga. E-pasts: Vija. [email protected]

Izdevums ir ISDB biedrs no 1995. gadaLasiet arî internetâ www.zva.gov.lv un www.farmacija-mic.lv

Aicinâm sûtît jautâjumus un ieteikumusVija Berlande, Zâïu valsts aìentûra, Jersikas ielâ 15, Rîga, LV-1003, tâlrunis 7078422, fakss 7078428elektroniskâ pasta adrese: [email protected]ârtçjo Cito! numuru varat saòemt Zâïu valsts aìentûrâ (ZVA), VOAVA, rajonu slimokasçs, profesionâlajâsasociâcijâs, Latvijas Ârstu biedrîbâ (LÂB)

24 Cito! � 3 (21) Zâïu valsts aìentûra